clinical research associate skills required

Top 12 Clinical Research Associate Skills to Put on Your Resume

Crafting a standout resume as a Clinical Research Associate requires a strategic showcase of your most pertinent skills, demonstrating your proficiency in navigating the complexities of clinical trials and data management. Highlighting the top 12 skills in your arsenal can significantly elevate your candidacy, underscoring your ability to excel in this detail-oriented and critical-thinking-driven field.

Clinical Research Associate Skills

• GCP Compliance
• Protocol Adherence
• Patient Recruitment
• Data Management
• Regulatory Submissions
• Safety Monitoring
• EDC Systems
• Medidata Rave
• CTMS Experience
• SOP Development
• IRB Interactions
• Pharmacovigilance

1. GCP Compliance

GCP Compliance refers to adherence to Good Clinical Practice guidelines, which are international ethical and scientific quality standards for designing, conducting, recording, and reporting trials that involve human participants. For a Clinical Research Associate, it involves ensuring that clinical trials are conducted and documented in a way that protects participants' rights, safety, and well-being, while also providing reliable trial results.

Why It's Important

GCP (Good Clinical Practice) compliance is crucial for a Clinical Research Associate as it ensures the ethical and scientific integrity of clinical trials, safeguarding participant safety and ensuring data credibility, thereby facilitating regulatory approval and public trust in medical research outcomes.

How to Improve GCP Compliance Skills

Improving GCP (Good Clinical Practice) compliance involves ensuring that clinical trials are conducted ethically, safely, and efficiently, adhering to guidelines that protect participants and ensure data integrity. For a Clinical Research Associate (CRA), focusing on the following areas can enhance GCP compliance:

Education and Training : Continuously update your knowledge on GCP guidelines and regulations. Consider enrolling in NIH's GCP training or courses provided by ACRP .

Documentation : Maintain accurate, timely, and complete documentation. Follow the ALCOA principle (Attributable, Legible, Contemporaneous, Original, Accurate) for all data and documentation practices.

Ethical Considerations : Always prioritize participant safety and rights. Familiarize yourself with the Declaration of Helsinki for ethical principles in medical research.

Audit and Inspection Readiness : Regularly review and audit trial processes and documentation to ensure readiness for inspections. The FDA's Bioresearch Monitoring (BIMO) Program offers insights into what inspectors look for.

Effective Communication : Maintain clear and continuous communication with all stakeholders, including the trial team, sponsor, and regulatory bodies. This ensures any issues are promptly addressed and corrected.

Risk Management : Implement a risk management plan to identify, assess, and mitigate risks throughout the trial. The ICH E6(R2) Guideline introduces a risk-based approach to GCP.

Technology and Tools : Utilize technology and tools designed for clinical trial management and GCP compliance, such as Veeva Systems or Medidata Solutions .

Focusing on continuous improvement, staying informed about regulatory updates, and leveraging technology can significantly enhance GCP compliance in clinical research.

How to Display GCP Compliance Skills on Your Resume

2. Protocol Adherence

Protocol adherence in the context of a Clinical Research Associate refers to the strict following of the study protocol as designed for a clinical trial, ensuring that all procedures, patient care standards, and data collection methods are carried out exactly as specified to maintain the integrity and validity of the research.

Protocol adherence is crucial in clinical research to ensure the integrity, reliability, and validity of study data, safeguard participant safety, and comply with regulatory requirements, thereby supporting the development of safe and effective treatments.

How to Improve Protocol Adherence Skills

Improving protocol adherence, especially for a Clinical Research Associate (CRA), involves a few key strategies:

Training & Education : Ensure all study team members, including investigators and site staff, receive comprehensive and ongoing training on the protocol. Tailored training can address specific areas of concern or complexity within the study. NIH Training

Clear Communication : Maintain open, clear, and consistent communication channels with all stakeholders. Regularly scheduled meetings and updates can help address issues as they arise. Society for Clinical Research Sites (SCRS)

Monitoring & Support : Conduct regular and thorough monitoring visits to ensure protocol compliance, provide support, and address non-adherence issues promptly. Utilize risk-based monitoring techniques to focus on critical study parameters. Clinical Trials Transformation Initiative (CTTI) - Monitoring

Feedback Mechanisms : Implement a system for feedback and queries that allows site staff to quickly get clarifications on protocol requirements, reducing the risk of non-adherence due to misunderstandings. Association of Clinical Research Professionals (ACRP)

Incentivize Compliance : Recognize and reward sites and team members who consistently adhere to the protocol. This could be through formal recognition programs or through feedback that highlights their contribution to the study's success. Clinical Leader - Improving Site Performance

By focusing on these strategies, a CRA can significantly improve protocol adherence across clinical trial sites.

How to Display Protocol Adherence Skills on Your Resume

3. Patient Recruitment

Patient recruitment in the context of a Clinical Research Associate refers to the process of identifying and enrolling eligible participants into clinical trials to ensure the study meets its enrollment targets efficiently and ethically.

Patient recruitment is crucial for a Clinical Research Associate as it ensures the availability of a sufficient and appropriate pool of participants to conduct reliable and statistically significant clinical trials, thereby enabling the assessment of the safety and efficacy of new treatments or interventions.

How to Improve Patient Recruitment Skills

Improving patient recruitment for a Clinical Research Associate involves several strategies aimed at streamlining the process and ensuring a diverse and qualified participant pool. Here are key steps:

Leverage Digital Platforms : Utilize social media, online forums, and health-related websites to reach a wider audience. Tools like Facebook Ads can be targeted towards specific demographics. Facebook Business provides insights on creating effective ad campaigns.

Engage with Patient Communities : Connect with patient advocacy groups and online communities. Establishing a presence in these networks can help in gaining trust and interest. PatientsLikeMe is a platform where people share their health experiences and can be a valuable resource for engagement.

Optimize Clinical Trial Websites : Ensure that your trial's website is user-friendly, mobile-optimized, and provides clear, accessible information about the study. The NIH provides guidelines on creating and managing clinical trial websites .

Utilize Electronic Health Records (EHR) : EHR systems can be used to identify potential participants who meet the study criteria. This can significantly reduce the time spent on manual screening. The American Medical Association outlines strategies for using EHR for clinical trial recruitment.

Referral Programs : Encourage current participants to refer others they know who might be eligible. Word-of-mouth can be a powerful tool in expanding your participant base.

Collaborate with Healthcare Providers : Build relationships with doctors, nurses, and other healthcare providers who can refer their patients to your trials. The Society for Clinical Research Sites offers resources on building and maintaining these relationships.

By implementing these strategies, Clinical Research Associates can enhance their patient recruitment efforts, ensuring a smoother, more efficient trial process.

How to Display Patient Recruitment Skills on Your Resume

4. Data Management

Data management in the context of a Clinical Research Associate (CRA) involves the systematic process of collecting, verifying, storing, and analyzing data generated from clinical trials to ensure accuracy, confidentiality, and integrity of the data for decision-making and regulatory compliance.

Data management is crucial for a Clinical Research Associate as it ensures the accuracy, integrity, and reliability of clinical trial data, facilitating regulatory compliance, effective decision-making, and ultimately safeguarding patient safety and research validity.

How to Improve Data Management Skills

Improving data management, especially for a Clinical Research Associate, involves adopting strategies that ensure accuracy, security, confidentiality, and compliance with regulatory standards. Here are concise steps:

Standardize Processes: Implement Standard Operating Procedures (SOPs) for data collection, entry, and verification to minimize errors and ensure consistency.

Training: Provide ongoing training for staff on data management practices, including the use of software and adherence to regulatory requirements.

Use of Technology: Leverage Electronic Data Capture (EDC) systems to streamline data collection and analysis, improving accuracy and efficiency.

Data Review and Monitoring: Regularly review and monitor data for inconsistencies or errors using Risk-Based Monitoring (RBM) techniques to focus resources on high-risk areas.

Compliance and Security: Ensure strict adherence to data protection regulations (e.g., HIPAA in the U.S.) and implement robust cybersecurity measures to protect sensitive data.

Quality Assurance: Conduct periodic audits and implement a Quality Management System (QMS) to evaluate the effectiveness of data management practices and identify areas for improvement.

By focusing on these key areas, Clinical Research Associates can significantly enhance the quality and reliability of their data management practices.

How to Display Data Management Skills on Your Resume

5. Regulatory Submissions

Regulatory submissions in the context of a Clinical Research Associate (CRA) involve preparing and submitting documentation to regulatory authorities (like the FDA in the US or EMA in Europe) to seek approval for conducting clinical trials, market drugs, or medical devices. These documents include clinical trial protocols, safety and efficacy data, and other necessary information to ensure compliance with regulatory standards and protect participant safety.

Regulatory submissions are crucial for Clinical Research Associates as they ensure that clinical trial protocols, data, and reports comply with regulatory requirements, safeguard participant safety, and maintain data integrity, facilitating the approval process for new medical interventions.

How to Improve Regulatory Submissions Skills

Improving regulatory submissions involves a strategic approach focusing on accuracy, completeness, and compliance. As a Clinical Research Associate (CRA), enhancing these submissions can be streamlined by following a few key steps:

Stay Informed: Regularly update your knowledge on regulatory guidelines and requirements from authoritative sources like FDA (U.S. Food and Drug Administration) or EMA (European Medicines Agency).

Preparation and Planning: Develop a comprehensive checklist based on the specific requirements for the submission. The ICH Guidelines provide a valuable framework for this.

Quality Data: Ensure all data is accurate, consistent, and verifiable. Utilize electronic data capture systems like REDCap or OpenClinica for efficient data management.

Effective Communication: Maintain clear and open communication lines with all stakeholders involved in the submission process. Regular meetings and updates can help in addressing issues promptly.

Timely Submission: Organize and schedule tasks to avoid last-minute submissions. Tools like Trello or Asana can aid in project management and deadlines tracking.

Continuous Learning and Feedback: After each submission, review the process to identify areas for improvement. Engage in training programs and workshops for ongoing learning.

By integrating these strategies, CRAs can significantly enhance the quality and efficiency of regulatory submissions, contributing to the success of clinical trials.

How to Display Regulatory Submissions Skills on Your Resume

6. Safety Monitoring

Safety monitoring in the context of a Clinical Research Associate (CRA) involves the ongoing process of identifying, assessing, and managing potential risks and adverse events related to a clinical trial to ensure the safety and well-being of participants throughout the study.

Safety monitoring is crucial for a Clinical Research Associate to ensure the well-being and safety of participants, identify and manage adverse events promptly, and ensure that the study complies with regulatory requirements and ethical standards. This process helps maintain the integrity and credibility of the clinical trial.

How to Improve Safety Monitoring Skills

Improving safety monitoring in the context of a Clinical Research Associate involves several key strategies focused on vigilance, compliance, and continuous learning. Here's a very short and concise description of how to enhance safety monitoring:

Enhance Training : Ensure comprehensive training in Good Clinical Practice (GCP) and specific safety monitoring procedures for all team members. The ACRP (Association of Clinical Research Professionals) offers resources and training modules.

Implement Risk-Based Monitoring : Utilize risk-based approaches to focus on critical data and processes affecting patient safety. TransCelerate Biopharma Inc. provides guidelines on risk-based monitoring.

Strengthen Communication : Establish clear, open lines of communication with the study team and site personnel to ensure timely reporting and addressing of adverse events. The Society for Clinical Trials offers resources on enhancing communication in clinical trials.

Utilize Technology : Adopt electronic systems for real-time data capture and monitoring, such as EDC (Electronic Data Capture) systems, which can flag abnormalities or deviations promptly. Veeva Systems and Oracle Clinical offer solutions in this area.

Conduct Regular Audits : Periodic audits help identify potential safety issues and non-compliance early. The ISO (International Organization for Standardization) outlines standards for clinical trial audits.

Stay Updated : Keep abreast of new regulations and guidelines from regulatory bodies such as the FDA (U.S. Food and Drug Administration) and EMA (European Medicines Agency) regarding safety monitoring in clinical trials.

By focusing on these strategies, Clinical Research Associates can significantly improve the safety monitoring aspect of clinical trials, ensuring better protection for participants and integrity of trial data.

How to Display Safety Monitoring Skills on Your Resume

7. EDC Systems

EDC Systems, or Electronic Data Capture Systems, are digital platforms used in clinical trials to collect, store, and manage data from study participants efficiently and securely. For a Clinical Research Associate, EDC Systems facilitate accurate monitoring, data verification, and real-time access to trial data, enhancing the quality and integrity of clinical research.

EDC (Electronic Data Capture) systems are crucial for Clinical Research Associates (CRAs) as they streamline and improve the accuracy of data collection, management, and analysis in clinical trials, ensuring regulatory compliance, enhancing data quality, and facilitating faster decision-making.

How to Improve EDC Systems Skills

Improving Electronic Data Capture (EDC) systems, specifically from a Clinical Research Associate's perspective, involves enhancing data quality, user experience, and system integration. Here are concise recommendations:

Enhance User Interface : Simplify the user interface for ease of use. This can lead to better compliance and fewer errors in data entry. Nielsen Norman Group provides excellent insights into usability principles.

Improve Training Materials : Develop comprehensive and easy-to-understand training materials. Utilize interactive e-learning platforms like Coursera or Khan Academy for examples of effective online learning.

Ensure Mobile Compatibility : Ensure the EDC system is mobile-friendly to allow for flexible data entry and access. The Responsive Web Design Basics by Google Web Developers offers guidelines for creating mobile-friendly websites.

Implement Real-Time Data Validation : Integrate real-time data validation to catch errors early. This can significantly improve data quality. Data Carpentry provides resources on data management best practices.

Enhance Security Measures : Strengthen security protocols to protect sensitive data. The National Institute of Standards and Technology (NIST) offers comprehensive guidelines on cybersecurity.

Facilitate Seamless Integration : Ensure the EDC system can easily integrate with other software and databases used in clinical trials. Health Level Seven International (HL7) standards can facilitate data exchange and interoperability.

Solicit User Feedback Regularly : Regularly collect feedback from users to identify areas for improvement. Tools like SurveyMonkey can be useful for gathering user insights.

Implement Adaptive Designs : Incorporate features that support adaptive trial designs, allowing for real-time modifications based on interim data analysis. The FDA Guidance on Adaptive Designs for Clinical Trials provides a regulatory perspective.

By focusing on these areas, Clinical Research Associates can contribute to the development of more efficient, user-friendly, and effective EDC systems.

How to Display EDC Systems Skills on Your Resume

8. Medidata Rave

Medidata Rave is a cloud-based platform used for electronic data capture (EDC), management, and storage in clinical research, enabling Clinical Research Associates (CRAs) to streamline data collection, ensure data accuracy, and facilitate monitoring and reporting activities for clinical trials.

Medidata Rave is crucial for a Clinical Research Associate (CRA) because it streamlines data collection, management, and analysis in clinical trials, ensuring accuracy, compliance, and efficiency in monitoring trial progress and outcomes.

How to Improve Medidata Rave Skills

Improving Medidata Rave for a Clinical Research Associate (CRA) involves enhancing data quality, streamlining study management, and leveraging training resources. Here’s a concise guide:

Enhance Data Quality : Utilize Rave's data validation tools to set up automatic checks for common data errors. This ensures data integrity and reduces manual review time. Medidata Solutions provides insights on leveraging these tools effectively.

Streamline Study Management : Familiarize yourself with Rave’s study management features, such as dashboards and reporting tools, to monitor study progress efficiently. The Rave EDC Essentials Training can help CRAs manage their studies more effectively.

Leverage Training Resources : Continuously improve your Rave proficiency by engaging with Medidata’s training and certification programs. These resources are designed to enhance your understanding and skills with the platform. Visit Medidata Academy for the latest courses and certifications.

Utilize Mobile Tools : Incorporate Rave's mobile applications to access real-time data and perform tasks on-the-go, enhancing flexibility and efficiency in your role. More information on mobile solutions can be found on the official Medidata Solutions Mobile page.

Participate in User Forums and Support Communities : Engage with other CRAs and Rave users in forums and support communities. These platforms are valuable for sharing tips, best practices, and solutions to common challenges. Medidata’s Community Page is a great starting point.

By focusing on these areas, CRAs can significantly improve their efficiency and effectiveness in using Medidata Rave for clinical trials management.

How to Display Medidata Rave Skills on Your Resume

9. CTMS Experience

CTMS Experience refers to the practical knowledge and skills a Clinical Research Associate has in using Clinical Trial Management Systems (CTMS), which are software platforms designed to manage the complexities of clinical trials. This experience involves overseeing trial progress, managing study sites, tracking patient recruitment, and ensuring data integrity and compliance with regulations.

CTMS (Clinical Trial Management System) experience is crucial for a Clinical Research Associate as it equips them with the necessary skills to efficiently manage and monitor clinical trials, ensuring data integrity, compliance with protocols, and effective communication across the study team. This proficiency leads to improved study outcomes and operational excellence in clinical research.

How to Improve CTMS Experience Skills

Improving the Clinical Trial Management System (CTMS) experience for a Clinical Research Associate involves streamlining data entry, enhancing training, promoting integration with other software, and ensuring robust support. Here’s a concise guide:

Streamline Data Entry : Simplify the interface and reduce redundancy. Utilize features like auto-fill and templates for common data points. Oracle's tips on efficient data management can be helpful.

Enhance Training : Offer comprehensive and ongoing training sessions. Ensure resources are easily accessible. Veeva Systems provides examples of training modules and user support.

Promote Integration : Ensure CTMS can seamlessly integrate with other systems (e.g., EHR, ePRO). This Medidata Solutions guide highlights the importance of system integration.

Ensure Robust Support : Provide immediate access to technical support and user forums. Establish a feedback loop for continuous improvement. Bio-Optronics offers insights into support structures and community forums.

Implementing these strategies can significantly enhance the CTMS experience for Clinical Research Associates, making their work more efficient and less stressful.

How to Display CTMS Experience Skills on Your Resume

10. SOP Development

SOP Development in the context of a Clinical Research Associate involves creating, updating, and maintaining Standard Operating Procedures (SOPs) to ensure clinical trials are conducted in compliance with regulatory requirements, ethical standards, and scientific validity. These SOPs provide detailed, step-by-step instructions for performing clinical trial-related tasks and processes consistently and efficiently.

SOP (Standard Operating Procedures) development is crucial for Clinical Research Associates as it ensures consistency, compliance, and quality in clinical trials by providing clear, step-by-step guidelines for conducting research activities, thereby safeguarding participant safety and data integrity.

How to Improve SOP Development Skills

Improving SOP development for a Clinical Research Associate involves a structured approach to ensure clarity, compliance, and efficiency. Here's a concise guide:

Understand Regulatory Requirements : Familiarize yourself with regulatory guidelines from bodies like the FDA and EMA to ensure SOPs meet all legal and ethical standards.

Engage Stakeholders : Involve various stakeholders, including clinical research coordinators and investigators, in the SOP development process for comprehensive input. Engagement can lead to more practical and widely accepted procedures.

Use Clear Language : Ensure SOPs are written in simple, clear language to avoid misunderstandings. Tools like the Plain Language Action and Information Network (PLAIN) can provide guidance on writing clearly.

Incorporate Best Practices : Research and integrate industry best practices into your SOPs. Resources like the Society of Clinical Research Associates (SoCRA) and the Association of Clinical Research Professionals (ACRP) offer valuable information and guidelines.

Implement a Review Process : Establish a regular review cycle for SOPs to incorporate new regulations, feedback, and improvements. This ensures SOPs remain current and effective.

Training and Compliance : Once developed, conduct thorough training sessions for all relevant staff to ensure understanding and compliance. Regularly assess adherence to SOPs and address any deviations.

Utilize Technology : Consider leveraging SOP management software for easier distribution, tracking, and updating of SOPs. Platforms like MasterControl or Veeva offer solutions tailored for clinical research settings.

By following these steps and utilizing the provided resources, you can enhance the development of SOPs, thereby improving the efficiency and compliance of clinical research activities.

How to Display SOP Development Skills on Your Resume

11. IRB Interactions

IRB Interactions for a Clinical Research Associate involve communication and coordination with Institutional Review Boards (IRBs) to ensure that all aspects of clinical trials comply with ethical standards, regulations, and the protection of study participants. This includes submitting study protocols for approval, reporting adverse events, and ensuring informed consent processes are followed.

IRB (Institutional Review Board) interactions are crucial for a Clinical Research Associate (CRA) as they ensure the ethical conduct of clinical trials, protect the rights and welfare of participants, and verify the integrity of data collected. This fosters regulatory compliance and public trust in clinical research.

How to Improve IRB Interactions Skills

Improving interactions with Institutional Review Boards (IRBs) is pivotal for Clinical Research Associates (CRAs) to ensure studies run smoothly and ethically. Here are concise strategies:

Understand Regulations : Familiarize yourself with FDA regulations and ICH guidelines for clinical trials. Knowing these rules helps in preparing compliant documents and responses.

Preparation and Organization : Ensure all documents are complete, accurate, and organized before submission. Utilize checklists provided by IRBs or create your own based on IRB submission guidelines .

Timely Communication : Respond promptly to IRB queries and requests. Establishing a proactive and responsive communication channel can significantly ease the review process.

Educate Your Team : Make sure all team members, including investigators and study coordinators, are informed about IRB processes and expectations. A well-informed team can avoid common pitfalls.

Build Relationships : Strive to develop a positive working relationship with the IRB staff. Understanding their processes and challenges can foster mutual respect and smoother interactions.

Continuous Learning : Stay updated on changes in regulations and best practices through professional development courses and webinars .

By focusing on these areas, CRAs can enhance their interactions with IRBs, contributing to more efficient study approvals and amendments.

How to Display IRB Interactions Skills on Your Resume

12. Pharmacovigilance

Pharmacovigilance is the practice of monitoring the effects of medical drugs after they have been licensed for use, primarily to identify and evaluate previously unreported adverse reactions. For a Clinical Research Associate, it involves ensuring the safety and efficacy of pharmaceutical products through diligent monitoring, reporting, and analysis of adverse event data collected during clinical trials.

Pharmacovigilance is crucial for Clinical Research Associates as it ensures the safety and well-being of patients by monitoring and evaluating the adverse effects of pharmaceutical products, thereby safeguarding public health and maintaining trust in healthcare products and practices.

How to Improve Pharmacovigilance Skills

Improving pharmacovigilance, especially from the perspective of a Clinical Research Associate (CRA), involves a multi-faceted approach focused on enhancing the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. Here’s a concise guide:

Enhance Training : Ensure continuous education and training on the latest pharmacovigilance practices and regulations. FDA Training and Continuing Education and EMA Training and Support offer resources for staying updated.

Strengthen Communication : Improve communication channels among all stakeholders, including patients, healthcare providers, and regulatory bodies. This facilitates the timely reporting of adverse events. The CIOMS Guidelines provide a standard for adverse event reporting.

Utilize Technology : Leverage technology such as electronic health records (EHRs) and pharmacovigilance software to streamline data collection and analysis. The WHO Pharmacovigilance Toolkit is a resource for implementing pharmacovigilance systems.

Implement Risk Management Plans (RMPs) : Develop and follow RMPs to identify, characterize, prevent, or minimize risks associated with pharmaceutical products. The EMA’s Guidelines on Risk Management Systems detail the creation and implementation of RMPs.

Conduct Thorough Monitoring and Reporting : Systematically monitor and report adverse events and other safety information. Utilize the FDA’s Adverse Event Reporting System (FAERS) for reporting in the USA, or the EudraVigilance system in Europe.

Engage in Continuous Quality Improvement : Regularly review and improve pharmacovigilance processes to adapt to new challenges and incorporate best practices. The ICH Guidelines offer a framework for quality improvement in pharmacovigilance.

Promote Patient Involvement : Encourage patient participation in the pharmacovigilance process through active reporting and feedback mechanisms. Resources like Patient Reported Outcome Measures (PROMs) can guide the integration of patient feedback.

By focusing on these key areas, a Clinical Research Associate can significantly contribute to the advancement of pharmacovigilance and ultimately enhance patient safety.

How to Display Pharmacovigilance Skills on Your Resume

Related Career Skills

• Clinical Research Assistant
• Clinical Research Nurse
• Clinical Research Coordinator
• Clinical Research Manager
• Clinical Researcher
• Clinical Trial Associate

6 skills to be a successful Clinical Research Associate: #SuccessFactors

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On the hunt for a fulfilling career as a clinical research associate here are six essential skills to consider for a successful career path as a cra at iqvia..

At IQVIA, we are tackling some of the biggest challenges in healthcare in pursuit of our mission to accelerate innovation for a healthier world. Our clinical research associates (CRAs) play a vital role in that effort, serving as overseers, conductors and documenters of our clients' clinical trials. 

CRAs at IQVIA are ambitious, passionate and bring a deep level of expertise to solve complex clinical issues while ensuring adherence to regulations and sponsor requirements. An IQVIA CRA’s ultimate goal is to deliver life-changing therapies as fast as possible, but without compromise.

Think this might be the career for you? Here are the top 6 factors to support a successful career as a CRA at IQVIA.

• 1. Communication

As a CRA, you are the key liaison between management, the study site, and the sponsor. With so many moving parts in clinical research, strong interpersonal skills and good command of English are important. It is also critical to have fluency in the local language of the respective country you work in. When difficult conversations come up, you’ll rely on these skills to effectively manage the situation and ask thoughtful questions. 

“Effective communication as a CRA comes down to considering your audience and their unique needs,” said Clinical Functional Service Provider CRA. “As a CRA, you regularly have conversations with healthcare professionals, management and site personnel, all with varying education levels, knowledge and skillsets. It’s important to read the room, know how your audience wants to receive information and pivot based on who you’re talking to.”

2. Relationship management 

A CRA builds relationships with all parties involved in the trial. Much like communication, there are nuances to these relationships. A great CRA knows when to lead versus support, can effectively manage through site-related issues and stays connected to study staff and research sites. 

“Relationship management is a pivotal component of monitoring,” said Senior CRA. “Establishing trust between yourself, as the CRA, and the sponsor and site staff help create a positive work environment for all parties. These relationships are beneficial to study compliance, productivity and collaboration so we can all achieve our end goal to improve patient outcomes.”

3. Attention to detail 

Keen attention to detail while executing site activities — initiation and start-up, recruitment, monitoring, site management and close-out — is critical to the quality and integrity of any study as the smallest error can lead to major consequences. As a CRA, your meticulousness in documenting how you conduct protocols, adhere to applicable regulations and capture site findings and action plans is foundational to the study’s success. 

“Find a tool that works best for you… it can be anything from old fashioned pen and paper, folders, spreadsheets or digital notes…whatever you choose, just be sure to capture everything you and the site have done and still need to do,” said Janet Robinson, senior CRA 3. “We work in an environment where everything is important, and if it’s not documented, it didn’t happen. An acute eye for detail will ensure that you keep accurate and timely notes at every stage. This will help later with time management, too!”

4. Critical thinking

Rapidly changing protocols, low patient recruitment and data errors are the norm in clinical research. As a CRA, you are the decision-maker, and the site team relies on your clinical expertise when it comes to spotting and solving problems. Critical thinking is key. If you spot a site-related issue or error that could impact data or patient safety, chart a course for corrective action. Study protocols, Good Clinical Practice (GCP) documents and operating procedures are all tools to support you in mitigating risk that could jeopardize the integrity of a study or cost the sponsor time and money. 

“Rather than letting adversity get you flustered, reflect on past experiences and use a ‘no time wasted’ approach to influence the outcome of a future project or milestone,” said Clinical Functional Service Provider CRA 2. “Take a step back to evaluate the situation, use your resources, training and past experiences to brainstorm potential solutions, and deliver quickly and compliantly.”

5. Time management

As a CRA, no two days are the same, and you must adapt to an ever-changing environment. A well-trained CRA must be able to effectively prioritize their time and juggle competing priorities across projects and site personnel to ensure the trial is carried out within the appropriate deadlines and within budget. 

As for managing your day-to-day responsibilities, sometimes figuring out where to begin is the biggest problem. Your task list can feel overwhelming, so a simple to do list is a great way to arrange your responsibilities. Rank your tasks by priority and tackle them one by one!

6. Stress management

Being a CRA is not always glamorous. There are long days on the road, rapidly changing protocols and monitoring reports to complete across multiple study sites. Treating patients with drugs for the first time can be stressful for patients and CRAs alike. 

“As a junior CRA, you have done the training, but now it’s time to pull all the pieces together, and that can be a daunting and overwhelming thought,” said Robinson. “Finding a mentor to field questions without judgement can help alleviate some of the stress. At IQVIA, we have a fantastic mentor program to help our CRAs navigate those early days and thrive through their career.” 

Off the job, find your outlet, whether that’s mediation, exercise, reading or spending time with family and friends. IQVIA is a huge proponent of work-life balance. We know you can’t be successful at your day job if you are not taking care of your mental, physical and social health, and we are here to support you to that end. 

What can you expect in return from IQVIA?

Love what you’ve read and think you’re a great fit for a CRA role?   Join us ! IQVIA offers a rewarding career path, compensation structure and development programs for CRAs. Our well-established training programs, access to cutting-edge technologies and the stability of a global organization enables you to have a long-lasting and fulfilling career journey as a CRA at IQVIA. 

“At IQVIA, we are committed to supplying our CRAs with the right tools, training and development support to allow for success and career growth,” said Dan Mink, director, Clinical Operations. “In addition to the rewarding work, collaboration and engaged line management, there is a constant focus on development as your career growth supports also the growth of the company.” 

Take the first step toward a fulfilling CRA career at IQVIA.  Apply to our CRA jobs today.

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25 Soft Skills for Clinical Research Associates (CRA) and Coordinators (CRC)

• by Kunal Sampat
• June 16, 2019
• in Clinical Operations

As clinical research professionals, we often hear about GCP, HIPAA, compliance, monitoring, Code of Federal Regulations (CFR), so on and so forth.

When trying to secure that next promotion, we often focus on our clinical research skills: the ability to enroll a trial fast, locking that trial database on schedule or passing the FDA audit.

Rarely we take a step back and think about soft skills. Today soft skills are more important than ever. It would be too dangerous to ignore them.

In this post, I’ll share my top 25 favorite soft skills in a clinical research context. You can leverage these soft skills in all areas of your life as well.

So let’s get started:

1. Adaptability to changing requirements

Globalization and harmonization continue to change the clinical research landscape. For example, in the medical device world, the most talked-about changes are the European Medical Device Directive (MDD). There is a lot of buzz on this topic (and complaining too).

Last year I attended a one day roadshow hosted by BSI Group. The presenter asked people to raise their hands if they had read the draft MDD. Less than 5 people in a room of 100+ attendees raised their hands. This goes to show how underprepared the audience was. Very few people had invested the time to understand the proposed changes to the MDD. Yet most of us we anxious about how the change was going to impact our work.

The question you must ask yourself “how will I adapt to these changes?” Change is not limited to government regulations. You’ll experience unanticipated changes in your department, your role, or your project. Take some quiet time to understand change and then adapt.

Change is always hard because it forces us to break our old habits and form new habits.

2. Authenticity and consistent behavior

Being authentic and consistent is hard work.

For example, if you are CRA responsible for on-site monitoring, you probably expect the research coordinator to respond to your emails, answer open queries and complete data entry in a timely manner. When you visit the site, you want the research coordinator to welcome you with a smile.

However, as a CRA, you are equally responsible for authentic and consistent behavior. As CRA you need to show up on time for the monitoring visit, send out monitoring follow-up letters within a few days of your visit (not weeks or months), and answer research coordinator questions with great accuracy and a smile.

Many of us fail to see the other side of the equation, especially when we feel we are in charge of the situation. Being authentic and consistent is hardest when no one is watching us.

3. Coach-ability and the desire to coach others

When I was a CRA, I remember my project manager required our team to cross-train each other. At that time, I thought cross-training was a waste of time. Obviously the project manager wanted team members to be cross-trained, should someone decide to quit their job.

But aside from this obvious reason for coaching others, there are many other benefits. If you take the time to teach someone how to use the excel spreadsheet you’ve created or explained the clinical jargon in the protocol, they’ll always remember you for helping them succeed. This, in turn, creates a lot of goodwill and karma.

4. Collaborative mindset

You may have heard a coworker say, “He is very territorial.” Rather than being afraid of others eating our share of the pie, we must develop an abundance mindset. The more willing you are to collaborate with our fellow colleagues, the more respect you’ll earn. This, in turn, will create opportunities for you and others.

Clinical trials require cross-functional expertise to succeed. Every person involved in the clinical trial has a role to play. Learn to collaborate with an open and curious mind.

5. Conscientiousness in keeping promises

When was the last time you or someone you know, made a promise and couldn’t keep it? I bet you can think of at least one situation in the recent past.

As clinical research professionals, we’re constantly bombarded with requests from sites, sponsors or our management. We generally agree to everything that gets sent our way. It’s hard to say “No”, especially to someone who we wish to please.

But what’s worse is that you get overwhelmed and can’t keep your promises. This leaves a bad impression with the other person.

Before you make your next promise, think about everything you have going on personally and professionally. You can always ask for time to think about the request before making a commitment.

6. Customer service passion

Whether you work at a clinical site, sponsor, clinical research organization (CRO) or the government, providing exceptional customer service to internal and external stakeholders can go a long way in building strong and positive working relationships.

Let’s use CRO-sponsor relationship as an example. The CRO works for the sponsor. It’s expected that the CRO provides excellent customer service to the sponsor. How about the sponsor providing excellent customer service to the CRO as well?

Sponsors can help CROs be successful at their job by documenting clear expectations, addressing areas of ambiguity and being transparent.

When I’m frustrated with customer service, I say to myself, “They are trying to do their very best.” This immediately puts me in a mindset of acceptance and empathy.

7. Eagerness to learn from criticism

Whether you work at an organization or run your own clinical research business, you can’t escape from criticism. There will always be someone who is going to be unhappy with you. Rather than reacting to the criticism, you must welcome it with both hands and learn from it.

Sites criticize sponsors for creating a complex clinical protocols, sponsors criticize regulatory agencies for not accepting their clinical strategy, and a CRO criticizes sponsors for being too demanding at all times.

Spend the time to understand the root cause for such criticism. It might be worth having discussions in a team environment to dissect the cause and how you can learn and improve in the future.

8. Enthusiasm for the work

Yawning is contagious. So is enthusiasm. If you’re enthusiastic for the work, you’ll get others excited too. Your output at work will be much better too.

Bored to read that Standard Operating Procedure? Or don’t want to write that clinical study report? Well, the good news is that everyone experiences dull moments. Enthusiasm is what keeps us going.

9. Ethics even when not under scrutiny

Clinical research and ethics are two sides of the same coin. For example, you don’t want to to take shortcuts by not following procedures. The impact of your decision to take shortcuts can result in a serious audit finding years later.

10. Managing difficult conversations

Difficult conversations can be emotionally exhausting. I remember several difficult conversations I’ve had over the years, particularly with employees who were a misfit for the organization.

If you’re a people manager, you need to learn the art of having difficult conversations with your team. If there are performance concerns, don’t wait till that next annual review. Be proactive and provide ongoing feedback – good and bad. People appreciate knowing where they stand.

11. Motivated to take on new challenges

Sooner or later you’ll be asked to take on new challenges, asked to do things that make you uncomfortable. Some challenges are more direct and others are subtle. For example, if you are a clinical research assistant, you maybe notice that the team needs help with some higher-level work to meet a timeline. Put yourself out there and make it known that you are willing to take on new challenges.

Remember that there may not be any immediate financial benefits to you. However, it is certain that you’ll grow personally and professionally as a result of taking on the new challenge.

12. Self-awareness

If there is one soft skill you must master on this list, it’s self-awareness. As clinical research professionals, we’re constantly interacting with various stakeholders. Before reacting to any situation, you want to be in full control of yourself by being self-aware.

For example, if you are choosing to take a tough stance on an issue, be sure to understand the “why” behind your decision. Don’t be tough for the sake of being tough. Put yourself in the other person’s shoes before you call the shots.

13. Sense of humor

A few years ago, I recollect a conversation between a Clinical Vice President (VP) and a well-respected clinician. The clinician wanted to design a large sample size study. But there was no scientific or statistical reasoning behind the clinician’s proposal. The VP was quick to comment, “I’ve never heard you be so unscientific in all the years we’ve worked together” The VP’s comment broke everyone into laughter, making it easier to have the much harder conversation of reducing the sample size.

Clinical research is a regulated industry. We’re always talking about compliance, patient safety, and good clinical practice. A sense of humor can put you and your colleagues at ease and not take everything so seriously.

14. Diligence and attention to detail

Paying attention to details is exceptionally important. Some people, intentionally or unintentionally, just don’t pay attention to details.

For example, if you are planning an investigator meeting, you need to understand pay attention to meeting logistics and content. Why? Because you’re inviting physicians and research coordinators to spend anywhere between 2-16 hours on your project. If you expect them to the attentive during your presentations, the meeting flow needs to be top-notch with every single detail mapped out.

Another area where attention to detail is necessary is medical writing. Writing clinical reports is not an easy task. Combined that with paying attention to document formatting and grammar can be daunting. If you are not good with formatting documents, learn to master the skill or outsource the work.

15. Facilitation of discussion

We’ve all been through painful meetings. People give boring “updates” on a project or simply digress on the least important topic on the agenda.

Facilitating an effective discussion by asking the right questions will help you a long way. When holding meetings, you need to think about the purpose of your meeting and focus on achieving that purpose. If the purpose is to provide updates, more often than not, it can be achieved through a well-crafted update summary. People can read the summary at a time that works best for them.

16. Listening skills

A few years back, my manager at the time gave four bullet feedback. One of the bullets read, “Talk Less, Listen More.” As humans, we love to talk. But if you can master the art of listening, you’ll start to understand what really matters to the person you are communicating with. Once you know what matters, you can tailor your response to address that person’s question or concern.

We’ve all been on a few teleconference calls where people are talking over each other. Let’s not do that.

17. Managing up

When you land with your first job, no one tells us that you need to learn how to “manage up.” You may be putting in a ton of hours at work. Yet your manager may be disappointed with your performance.

Seldom do managers want to give their employees a hard time. In fact, it’s in the best interest of the manager to keep an employee happy at work. Learning to manage up, gives you the ability to get in sync with your manager.

For example, a site investigator may expect the research coordinator to lead a dozen clinical studies. The coordinator single-handedly can’t possibly manage such a heavy workload without burning out. But the coordinator can track how long it is taking her to perform her tasks. She can share this data with the investigator to discuss potential options to make her workload more manageable.

When you are managing up, don’t be defensive. Instead explain the issue you are facing in a calm and objective manner, backed by real data.

18. Planning for projects

Planning for projects shouldn’t be left to the project manager. Although it’s nice if the project manager did all the project planning for us. As a clinical researcher, you likely have your own projects or deliverables.

For example, a clinical quality manager may be responsible for developing or updating standard operating procedures. She would need to allocate focused time to update procedures, schedule time with other team members to get their input t on the procedure changes, read FDA guidance documents to understand the regulatory landscape and more.

Planning for projects can be boring because you’re tempted to spend that extra time on doing the work itself and planning seems like a huge waste of time. However, when you actually sit down and write your plan on paper, it helps bring clarity to your mind and work.

19. Technology savvy

I love technology. It helps us do our work faster and better. I won’t argue with you if you told me technology also leads to issues that can take a long time to fix. But overall, we are net positive with technology.

As a clinical research industry, we should leverage technology to make research more interesting and engaging. Being tech-savvy doesn’t end once you learn how to use Microsoft Word, Excel, PowerPoint or Electronic Data Capture (EDC) systems.

For example, sponsors can use email software such as Marketo to send out well-designed clinical trial newsletters to research sites rather than sending an email with a PDF attachment that very few people bother to open.

Other ideas include the use of electronic informed consent solutions (eICF), transfer imaging data online rather than via courier services or using social media to recruit patients.

20. Conflict resolution instincts

We’re prone to conflicts because each one of us has a unique worldview. This leads to disagreements. Developing conflict resolution instincts can take years of practice. One strategy I’ve found particularly useful is putting myself in the other person’s shoes.

For example, let’s assume you and your colleague are disagreeing with the clinical protocol design. It would be wise for you to take the time to understand your colleagues’ concerns. Discuss or think through the concerns one-by-one and be creative about mutually resolving disagreements.

Ultimately a few concerns will need to be elevated to senior leadership. But at least you and your colleague would have vetted out most issues before escalating to the next level.

21. Creativity in the face of challenges

It is quite common to face challenges when conducting research.

It’s taking months to negotiate a clinical trial contract, the CRO is not meeting sponsor expectations, patient recruitment is significantly slow and an audit led to major findings are some common challenges.

Rather than reacting to these challenges, it’s important to take a step back and brainstorm all potential solutions to the challenge at hand. In order to come up with creative solutions, you need to have an open and curious mind.

22. Dealing with difficult people

There are many ways to deal with difficult people. You approach will vary depending on whether the difficult person you are dealing with is your subordinate, supervisor or colleague.

My only suggestion when it comes to dealing with difficult individuals is that you conserve your finite amount of energy. If you drain your energy in trying to correct other people, you’ll distract yourself from fulfilling your own dreams and doing work that actually matters.

23. Diplomacy in difficult situations

The author Maya Angelou once said, “I’ve learned that people will forget what you said, people will forget what you did, but people will never forget how you made them feel”.

When you find yourself in difficult situations, don’t say things that will hurt the other person or make them feel bad about themselves.

I also find myself using silence as a way to gather my thoughts before speaking my mind in difficult situations.

24. Storytelling

You may feel that storytelling does not apply to clinical research. But actually, take a minute now to think about any talk or presentation you thoroughly enjoyed. I bet the speaker was harnessing the power of storytelling.

Humans love stories. Therefore the next time you are invited to present at an investigator meeting or a site initiation visit, practice storytelling. Don’t read the slides verbatim because no one will remember you or what you said.

25. Empathy for customers, co-workers, and vendors

Being able to understand the feelings of our customers, coworkers and vendors make us more approachable. People will want to connect with you if you care about them. Showing empathy is not a sign of weakness but rather of strength and maturity.

For example, assume you are a CRA out at a site for a monitoring visit. If the research coordinator is stressed about missing patient records, you can express empathy by acknowledging the coordinator’s efforts in trying to find the missing records. The missing records won’t magically appear. However, the coordinator will recognize the fact that you are able to understand her plight.

We’ve covered 25 foundational soft skills that will serve well in your clinical research career. In order to put these skills to practice, pick just one soft skill and practice it for 30 days. Then see what magic is done for you. At the end of 30-days, spend 30 minutes reflecting what worked well and what didn’t. Then move onto the next skill of your choice. Within a year, you would have mastered 12 soft skills. That’s a lot!

Let me know if which soft skill you’re planning to put into practice next and why? I’d love to hear your thoughts, ideas, and suggestions in the comments sections below.

Clinical Project Management with Antoinette (Torres) Frankum

Ctp 021: getting into research and cro partnerships with jessie coe, 14 thoughts on "25 soft skills for clinical research associates (cra) and coordinators (crc)".

Dr chitrangda

I am about to start my career as a clinical researcher, these points sounds helpful to me. Thank you.

Kunal Sampat

Great, I’m glad to hear.

I am a PhD in oncology. There’s a job opening which asks what relevant skills do you bring with you for CRA role. What should be my response? It should be something exceptional which I cant think of! Please help.

I would suggest that you make a list of ALL the skills you have acquired as part of your education, work or hobbies. Then identify 3-5 top skills that are relevant to the CRA role. Then use examples to demonstrate what makes you exceptional. At the end of the day, soft skills trump technical skills. Both are important but if you’re not able to work with other people, it can be challenging to work in teams. So your response should be a combination of soft skills from this blog post and a few other technical skills you possess. Goodluck!

I have found his quite helpful. I am currently interviewing for a position as a CRA with a background in lab based science (RA). I find myself with at least some ability in all of these soft skills. I hope to find a fit as a CRA and it may help me with my insatiable quest for all things ambitious.

Ridhima Patel

This information is so gonna help who are fresher and want to enter in this field and thanks for that because i am one of them

Hi Kunal, All soft skill you have given in this blog regarding CRC and CRA are very helpful for me, I am M.Pharmacy fresher and I am seeking for CRA profile so your content is like study material for me. Thanks for sharing – Divya Shetty

you are welcome, Divya

Yvonne Gautam

Thanks, a really good and thoughtful overview. I am just moving jobs from one CRC role to another, so have been reviewing how I can improve my performance going forward. I think you pick out 25 very important skills. Your suggestion to practice one soft skill per months is a great idea.

Thank you for this! I just came across this post on a Google search, and even though my career is in a completely different domain, these points are very relevant to any career and are the keys to success. They are the skills that are often lacking in the workplace and are difficult, if not impossible to teach. It’s certainly easier to teach someone how to use Excel than trying to teach enthusiasm or listening skills!

Rutuja Ware

Hey, I’m a final year grad student. Looking forward to exciting opportunities in the clinical research field. I came across your podcast, which seemed very promising. This can help a lot in preparing for interviews in a multifaceted manner. Thank you so much for sharing! Best wishes.

Hello, This is good content to read. Am a clinician aspiring to be a CRA and I will be learning adaptability to new requirements

These soft skills can really make someone a very organised, competent and lovely CRA. I have to start practicing now

I’m glad to hear you’ve started practicing now. According to US Department of Labor, 3 out of 5 skills for Natural Science Managers are soft/ people skills i.e. interpersonal skills, leadership skills, and time management skills.

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Clinical Research Associate skills for your resume and career

Clinical research associates need a range of technical skills to succeed in their field. These include expertise in clinical trials management, site monitoring, and data collection. They also require a thorough understanding of regulations, such as those set by the FDA and ICH. They must be able to perform informed consent and ensure that sites are compliant with applicable local requirements.

In addition to technical skills, clinical research associates need strong soft skills. They must be able to communicate effectively and work well in teams. As Michael Brown , Morris L. Clothier Professor of Physics at Swarthmore College, says, "Our graduates learn physics analysis and problem solving skills, but also computer modelling skills, experimental techniques, writing skills, and even how to make an effective presentation." They must also be able to work well with others, collaborate, and play well with others.

15 clinical research associate skills for your resume and career

1. patients.

Patients are individuals receiving medical care or participating in clinical trials. Clinical research associates use patients by verifying their eligibility for clinical trials, monitoring their progress, and ensuring their safety. They also enroll patients into studies, conduct consent interviews, and collect data from their medical records.

• Chart review of patients undergoing angioplasty procedures or other admitting diagnoses at the MedStar Washington Hospital Center per current review requirements/request.
• Monitored and summarized computer based reports of patients enrolled and forms received and report to data analyst and study coordinator.

2. Informed Consent

Informed consent is the process of obtaining a person's consent before conducting a medical procedure or research study. Clinical research associates use informed consent by preparing and maintaining specialized documents, such as case report forms and in-service manuals, and by educating potential participants in clinical studies. They also ensure that informed consent is administered properly and that all documentation is accurately maintained within the company database.

• Proofread FDA /Informed Consent Forms and collected soft copies of personnel certifications/disclosure agreements while maintaining all documentation within the company database.
• Provided detailed information to eligible patients in an effort to obtain informed consent to enrollment, and subsequently filed appropriate paperwork.

CRA stands for Clinical Research Associate. Clinical Research Associates use CRA to manage site assignments and oversight of clinical monitoring activities. They also work with management on monitoring strategy and develop project-specific CRA training. As Bart Elmore , Associate Professor of Environmental History at Ohio State University, puts it, "These students are not taught highly technical skills that only apply to one craft or profession. Rather, they are taught rigorous writing and researching techniques that can help them start a business, build a political campaign, or develop strategies to combat climate change."

• Served as a CRA with provider of outsourced development services to pharmaceutical and biotechnology industries.
• Worked with management on monitoring strategy, and/or developing project-specific CRA training.

4. Clinical Trials

Clinical trials are research studies that involve people and are designed to evaluate the safety and effectiveness of new medical treatments or products. Clinical research associates use clinical trials by supporting the site identification process, monitoring inpatient and outpatient trials, and preparing presentations for clinical trial initiation meetings. They also manage monitoring activities for medical clinical trials, contract clinical research associate positions, and review and validate clinical trial data.

• Support the site identification process and evaluate potential qualified investigators and clinical sites for suitability to participate in the clinical trials.
• Managed and monitored inpatient and outpatient clinical trials, including identifying and resolving site issues, protocol compliance and regulatory issues.

5. Clinical Trial Management

Clinical trial management involves overseeing the operational aspects of clinical trials. Clinical research associates use clinical trial management to maintain communication, track data, and manage information. They update systems like the Clinical Trial Management System (CTMS) and use it to manage sites, track investigator recruitment, and ensure protocol adherence. They also use it for reporting and data entry purposes.

• Maintain clinical trial management systems effectively in order to ensure adequate communication to project team and sponsor.
• Perform data entry of regulatory documents and maintenance of Investigator information in the Clinical Trial Management System

6. Oncology

Oncology is the diagnosis and treatment of cancer. Clinical research associates use oncology in various ways, such as developing and implementing research policies and procedures, recruiting and screening potential candidates for clinical trial eligibility, and managing regional academic and community-based oncology practices. They also coordinate daily department functions for pediatric oncology, maintain electronic databases for reporting oncology information, and monitor multiple oncology protocols.

• Develop and implement research policies and procedures and provide in-service training presentations to the Pediatric Hematology/Oncology nursing staff to ensure compliance.
• Recruited and screened potential candidates for clinical trial eligibility in the fields of children's oncology and hematology.

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7. data collection.

Data collection is the process of gathering information and data for research or analysis. Clinical research associates use data collection by managing clinical trials, formulating source documents, and managing data entry. They also collaborate with investigators and researchers to obtain technical data parameters for data collection. Additionally, they oversee and review data collection to ensure it's prepared for analysis. They design protocols, collect data, and analyze it for solution generation. They also monitor data collection and verify its accuracy. They develop databases to track and monitor data collection and develop rules and methodologies for data collection and analysis.

• Demonstrated competencies in managing clinical trials data, formulating source documents and data collection charts and severe adverse event reporting.
• Key Responsibilities:Manage clinical research projects assigned:on-site monitoring and data collection, assist protocol and CRF development

IRB stands for Institutional Review Board, a group that reviews research studies to ensure they're conducted ethically. Clinical research associates use IRB by reviewing and submitting regulatory documents, ensuring compliance with study expectations, and interacting with IRB officials. For example, they might review and prepare IRB applications, compile and ensure the completeness of regulatory documents, and monitor IRB reporting documents for accuracy and timeliness.

• Review approved/acknowledged information submitted to IRB as needed for thorough understanding of study expectations and updates.
• Interacted with IRB officials, project management and investigators to ensure compliance and accuracy of documentation.

ICH stands for International Conference on Harmonisation, which is a set of guidelines for clinical trials. Clinical research associates use ICH guidelines to ensure that clinical trials are conducted ethically and in compliance with regulations. They monitor sites to ensure that they are following the guidelines, conduct site visits to check for compliance, and review documents to check for accuracy and consistency with ICH guidelines. They also evaluate and monitor compliance with local regulations and ICH guidelines.

• Implemented and monitored clinical trial to ensure sponsor/investigator obligations were met and were compliant with applicable local requirements and ICH guidelines.
• Performed investigative site file reconciliation and reviewed essential documents for accuracy, consistency and compliance with ICH guidelines and sponsor requirements.

GCP stands for Good Clinical Practice. Clinical research associates use GCP to ensure that clinical trials are conducted in a standardized way and that the data collected is reliable and trustworthy. They use GCP to supervise and train research assistants, verify site suitability, and ensure compliance with regulations. They also review monitoring visit reports, perform GCP remediation activities, and provide guidance on GCP issues for medical devices. For example, a clinical research associate might review a site's regulatory documentation to ensure that it adheres to GCP guidelines. They may also design and present training sessions on GCP for physicians and their staff.

• Supervised and trained research assistants in interpretation of complex medical data, laboratory procedures, and GCP compliance
• Verified site suitability, subject inclusion/exclusion, IP accountability and GCP adherence.

The Food and Drug Administration (FDA) is a federal agency responsible for protecting public health. Clinical research associates use the FDA's guidelines to ensure that clinical trials are conducted safely and ethically. They recruit investigators, conduct monitoring visits, and audit and process regulatory documentation to ensure compliance with FDA regulations. They also maintain clinical study documentation in accordance with FDA regulations, and monitor clinical trials to ensure that all data submitted meets FDA requirements.

• Conducted qualification, initiation, interim and close-out monitoring visits in compliance with good clinical practices and FDA regulations.
• Recruited new physician investigators and inspected their offices, audited and processed regulatory documentation for submission to the FDA.

12. Data Management

Data management is the process of collecting, storing, and using data effectively. Clinical research associates use data management to review data listings, assist with query generation, and ensure data accuracy and integrity. They also work with data management centers to conduct clinical data listing reviews and optimize the process of query resolution. As a result, they can ensure timely completion and submission of Case Report Forms according to the Clinical Monitoring Plan and Data Management Plan.

• Reviewed data listings and assisted data management with query generation and sites with query resolution in preparation for database lock.
• Run Validated edit checks programs: Maintain knowledge of current regulations and technologies related to Data Management and Study related Standards

13. Site Management

Site management involves managing the day-to-day operations of a site. Clinical research associates use site management to recruit investigators, collect investigator documentation, and prepare monthly status reports. They also use it to ensure compliance with protocols and regulations, perform monitoring visits, and manage communication with sites.

• Administered clinical research projects; recruit investigators, collect investigator documentation, site management, and prepare monthly status reports.
• Performed investigator site management activities in adherence to all applicable regulatory guidelines, maintaining appropriate document collection and validation.

14. Site Monitoring

Site monitoring is the process of evaluating and ensuring the quality, integrity, and compliance of clinical trials. Clinical research associates use site monitoring to conduct visits, perform source document verification, review protocols, and ensure regulatory compliance. They also use site monitoring to evaluate data, generate queries, and prepare for visits. For example, they might prepare trip reports to summarize work accomplished at a site monitoring visit.

• Conducted site monitoring visits performing source document verification, protocol review, regulatory compliance, drug accountability and ongoing site evaluation.
• Evaluated electronically updated clinical data via Medidata-Rave for study progress, generation of queries and preparation for site monitoring visits.

15. Regulatory Submissions

Regulatory submissions are the documents and data used to apply for regulatory approval of a product or process. Clinical research associates use regulatory submissions in a variety of ways, including auditing and analyzing data to support technical reports and publications, contributing to the compilation of study reports, and monitoring regulatory compliance. They also review study site regulatory issues, advise study sites on regulatory submissions, and manage direct reports during a regulatory project.

• Audited, collected, tabulated, and analyzed clinical data as required to support technical reports, publications and regulatory submissions.
• Contributed to the compilation, organization and production of protocols, clinical study reports, regulatory submissions, and controlled documentation.

12 Clinical Research Associate Resume Examples

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List of clinical research associate skills to add to your resume

The most important skills for a clinical research associate resume and required skills for a clinical research associate to have include:

• Informed Consent
• Clinical Trials
• Clinical Trial Management
• Data Collection
• Data Management
• Site Management
• Site Monitoring
• Regulatory Submissions
• Consent Forms
• Clinical Sites
• Study Sites
• Clinical Practice
• Clinical Data
• Project Management
• Clinical Research Studies
• ICH Guidelines
• Site Selection
• Investigative Sites
• Study Start-Up
• Site Initiation
• Study Procedures
• Federal Regulations
• Trip Reports
• Excellent Interpersonal
• Query Resolution
• Excellent Computer
• Investigational Product
• Regulatory Compliance
• Drug Accountability
• Data Queries
• Routine Monitoring
• Field Training
• Study Initiation
• Site Compliance

Updated April 25, 2024

Editorial Staff

The Zippia Research Team has spent countless hours reviewing resumes, job postings, and government data to determine what goes into getting a job in each phase of life. Professional writers and data scientists comprise the Zippia Research Team.

Clinical Research Associate Related Skills

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• Laboratory Manager Skills
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Looking for keywords for a specific job search for your job title here., © 2024 resume worded. all rights reserved., clinical research associate resume keywords and skills (hard skills).

Here are the keywords and skills that appear most frequently on recent Clinical Research Associate job postings. In other words, these are the most sought after skills by recruiters and hiring managers. Go to Sample Templates ↓ below to see how to include them on your resume. Remember that every job is different. Instead of including all keywords on your resume, identify those that are most relevant to the job you're applying to. Use the free Targeted Resume tool to help with this.

• Good Clinical Practice (GCP)
• Clinical Monitoring
• Clinical Trial Management System (CTMS)
• Electronic Data Capture (EDC)
• Clinical Trials
• Clinical Research
•  Find out what your resume's missing
• Clinical Development
• CRO Management
• Clinical Research Associates
• Clinical Data Management
• Standard Operating Procedure (SOP)
• Therapeutic Areas
• Clinical Operations
• Oncology Clinical Research
• Regulatory Submissions
• U.S. Food and Drug Administration (FDA)
• Clinical Site Monitoring
• Biotechnology

Resume Skills: Regulations

• ICH Guidelines
• FDA Regulations
• Health Insurance Portability and Accountability Act (HIPAA)
• FDA regulations
• ICH guidelines
• Code of Federal Regulations Title 21
•  Match your resume to these skills

Resume Skills: Languages

• Spanish (Fluent)

Resume Skills: Software

• Oracle Clinical
• Medidata Rave
• Microsoft Office Suite (Excel, PowerPoint, Word)
• MS Office Suite
• ClinCapture
• OpenClinica
• EDC Systems
• Clinical Conductor
• Electronic Data Capture (EDC) Systems
• Statistical Software (SAS, SPSS)
• Microsoft Office
• Clinical Data Management System (CDMS)
• Biostatistics

Resume Skills: Technical

• Clinical Trial Data Reporting
• Electronic Health Records (EHR)
• Python for Data Analysis
• Clinical Data Management Systems (CDMS)

Resume Skills: Regulatory Knowledge

• ICH-GCP guidelines
• Clinical research ethics
• FDA guidelines
• Clinical Study Reports

Resume Skills: Project Management

• Stakeholder Management
• Risk Management
• Agile and Scrum methodologies
• Risk Assessment
• Contract Negotiation
• Time Management
• Decision Making

Resume Skills: Clinical Research

• Clinical Trial Design
• Regulations Compliance
• Scientific Writing
• Designing and Conducting Clinical Trials
• Regulatory Compliance
• Patient Recruitment
• Data Analysis
• Site Monitoring
• Report Writing
• Clinical Trials Management
• Drug Development Process
• Data Collection and Analysis
• Protocol Development
• Data Management
• Adverse Event Reporting
• Clinical Trial Protocols
• IRB Submissions
• Clinical Trial Monitoring
• Ethics in Clinical Research
• Clinical Trial Designs
• Data Collection & Analysis
• Clinical Trial Management
• Phase I-IV Trials
• Clinical Study Design
• Protocol development
• Clinical monitoring
• Regulatory compliance
• Data collection and analysis
• Quality Assurance

Resume Skills: Biomedical Techniques

• Molecular Biology Techniques
• Cell Culture
• Bioinformatics

Resume Skills: Technologies and Tools

• Medical Imaging Software

Resume Skills: Data Analysis & Statistics

• Python (Pandas, Numpy)
• Epidemiology

Resume Skills: Medical

• Medical Terminology
• Patient Care
• Medical Specimen Collection
• Microbiology Techniques

Resume Skills: Communication & Documentation

• Medical Reporting
• Protocol Writing
• Patient informed Consent forms
• Medical Review
• Medical Documentation

Resume Skills: Regulatory & Quality Assurance

• FDA Regulatory Guidelines
• Good Clinical Practices
• ICMJE Recommendations
• EMA Guidelines

Resume Skills: Regulation and Compliance

• Ethical Guidelines

  Where on my resume do I add these buzzwords? Add keywords directly into your resume's work experiences , education or projects. Alternatively, you can also include a Skills section where you can list your technical skills in order of your proficiency. Only include these technical skills or keywords into your resume if you actually have experience with them.

   Does your resume contain all the right skills? Paste in your resume in the AI Resume Scan ↓ section below and get an instant score.

Compare Your Resume To These Clinical Research Associate Skills (ATS Scan)

Paste your resume below and our AI will identify which keywords are missing from your resume from the list above (and what you need to include). Including the right keywords will help you get past Applicant Tracking Systems (i.e. resume screeners) which may scan your resume for keywords to see if you're a match for the job.

Sample Clinical Research Associate Resume Examples: How To Include These Skills

Add keywords directly into your resume's work experiences , education or skills section , like we've shown in the examples below. use the examples below as inspiration..

  Where on my resume do I add these buzzwords? Add keywords directly into your resume's work experiences , education or projects. Only include these technical skills or keywords into your resume if you actually have experience with them.

How do I add skills to a Clinical Research Associate resume?

Go through the Clinical Research Associate posting you're applying to, and identify hard skills the company is looking for. For example, skills like Electronic Data Capture (EDC), Good Clinical Practice (GCP) and Clinical Development are possible skills. These are skills you should try to include on your resume.

Add other common skills from your industry - such as Clinical Research, Clinical Trial Management System (CTMS) and Clinical Monitoring - into your resume if they're relevant.

Incorporate skills - like Clinical Research Associates, Oncology Clinical Research and Clinical Site Monitoring - into your work experience too. This shows hiring managers that you have practical experience with these tools, techniques and skills.

Consider including a section in your resume dedicated to your research experience. On Clinical Research Associate resumes, hiring managers want to see research projects which you led or where involved with, and their outcomes.

Try to add the exact job title, Clinical Research Associate, somewhere into your resume to get past resume screeners. See the infographic for how to do this.

Word Cloud for Clinical Research Associate Skills & Keywords

The following word cloud highlights the most popular keywords that appear on Clinical Research Associate job descriptions. The bigger the word, the more frequently it shows up on employer's job postings. If you have experience with these keywords, include them on your resume.

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Upload your resume and we'll spot the issues in it before an actual clinical research associate recruiter sees it. for free., clinical research associate resume templates.

Here are examples of proven resumes in related jobs and industries, approved by experienced hiring managers. Use them as inspiration when you're writing your own resume. You can even download and edit the resume template in Google Docs.

Resume Example Operations Associate (Entry Level Operations Manager)

An effective Description of the templates...

Download this resume template

Operations associates can learn about business operations as they work to support the day-to-day functioning of a company. While you do need to be organized and conscientious for this type of role, you don’t need management experience for this entry-level role -- so use your resume to underscore your education and internship history, as shown in this resume.

Tips on why this template works

   leads with educational experience.

As an entry-level applicant, you won’t have a lot of work history to discuss -- so start your resume off with what you have accomplished in school and internship experience. If you’ve done coursework in relevant areas such as data analytics or operating systems, it’s great to mention that up-front.

   Relevant internship experience

This resume points out accomplishments at internships that directly relate to being an operations associate. The bullet points show that even though you’re early in your career, you’ve already made an impact with your work.

Resume Example Sales Associate / Retail Salesperson

A retail sales associate, typically a sales associate working specifically in a brick-and-mortar store, must have excellent interpersonal skills and the emotional intelligence to interact with a variety of different customers daily. When crafting your retail sales associate resume, make sure to emphasize the relevant skills and experience you have developed in your past retail roles.

   Tailored retail work experience

Retail sales involves extensive face-to-face interaction with customers on a daily basis, and hiring managers are looking for candidates who can effectively handle the unique challenges that come up in this environment. Make sure to include as much relevant experience you have for the role -- even outside of just retail. For example, if you worked as a receptionist, you were often working face-to-face with an office’s clients. If you think outside the box like this, you can probably come up with more relevant experiences than you realize!

   Relevant skills in retail and sales

Focus on including retail-oriented skills in your skills section. Showing hiring managers that you have applicable experience in working a cash register, improving operations, or troubleshooting credit card issues can be the difference between landing a job or getting passed over. In addition, make sure you read through the job posting to see what skills they list, and emphasize the skills they’ve highlighted throughout your resume.

Resume Example Clinical Research Assistant

Clinical research assistants work on clinical trials in hospitals and medical research centers. As a clinical research assistant, you’ll be assisting doctors and senior researchers by recruiting and enrolling research subjects, developing protocols, setting up and managing trials, collecting and analyzing data, and contributing to trial reports, regulatory authority applications, and grant writing. Ideally, you’ll need some experience or a degree in the field of study and clinical trial experience.

   Focused on clinical research

When applying for a more specialized position like clinical research assistant, you want to keep your resume as tightly focused as possible. That means prioritizing clinical research experience. It’s fine to include general research experience, but try to tailor your bullet points by including accomplishments relevant to clinical research, like preparing regulatory documents and conducting medical research.

   Good use of skills section to highlight research skills and tools

Jobs that require a lot of hard skills, like clinical research, may end up with a larger than usual skills section. Avoid making recruiters’ eyes glaze over by splitting it into subsections, like certifications, techniques, and technical skills. Make sure you’re exclusively listing hard skills — employers want to see things like relevant software skills and clinical trial experience.

Resume Example Laboratory Research Assistant

As a laboratory research assistant, you’ll be working in a laboratory environment to design projects, conduct research and experiments, write reports, perform general laboratory maintenance, and assist senior laboratory staff — so make sure to emphasize your technical skills. You may be working for a private laboratory, medical or research facility, or pharmaceutical company. Unlike standard research assistant positions, lab assistants typically work full-time, including weekend and evening shifts.

   Bullet points feature strong action verbs

Every bullet point should start with a strong action verb. Remember, your resume is supposed to highlight your accomplishments, not simply list your job duties. As a laboratory research assistant, you’ll want to emphasize your scientific expertise. Verbs like Researched, Designed, and Developed all reflect the skills you’ll be expected to use on the job.

   Uses hard numbers and metrics

Including metrics in your bullet points is the best way to demonstrate the outcome of your work. This doesn’t mean every bullet point needs to include numbers but try to quantify your accomplishments whenever possible. If you analyzed data with 98% accuracy, reduced processing times by 25%, or performed research on 1,000 subjects, say exactly that.

Resume Example Graduate Research Assistant

Graduate research assistants are able to work while they study, receiving a tuition reimbursement or stipend as well as valuable experience working in academia. As a graduate research assistant, you’ll have completed an undergraduate degree and be pursuing a master’s degree or PhD. You’ll generally be working closely with a supervisor to support their projects, including conducting research, analyzing data, writing reports, and supervising undergraduate research assistants.

   Highlights university research projects

As a graduate research assistant, hiring managers won’t expect you to have extensive paid experience. If you’ve worked on previous research projects as a student, you can list these under your work experience or in an education or projects section. For greater impact, use action verbs and metrics to frame your accomplishments in an action-focused way.

   Includes a resume summary focused on graduate research interests and experience

Even as a graduate, you may have significant research experience, especially if you’ve been heavily involved in student research. You can highlight your skills and background with a short resume summary — no more than 100 words — explaining your years of experience, research or educational specialization, and 1-2 of your most impressive accomplishments.

Resume Example Chemistry Research Student

When applying to be a chemistry research student assistant, emphasize your past research experience and chemistry skills in your resume. Chemistry is a specific and precise discipline, and your resume should reflect these qualities. Aim to choose instances that detail your expertise in hands-on lab procedures or with relevant software, as opposed to simply listing out the responsibilities you were assigned. Use strong action verbs and be deliberate with what you include.

   Emphasize hard skills with metrics relevant to chemistry

As mentioned above, chemistry is a precise discipline -- you’re often working in the lab with dangerous chemicals or complex equipment. That means that the employers reading your resume -- labs, government agencies, or academic institutions -- are looking for evidence of your experience and skills in those areas. Do your research to find what types of software the job posting notes, whether that’s MATLAB, Solidworks, or ANSYS. Emphasize the hard skills you’ve learned through your past experience with powerful action verbs, and highlight your achievements with quantifiable metrics.

   Concise, informational chemistry resume summary

This resume makes great use of a concise, information-packed elevator pitch that is well-written and to the point. Chemistry recruiting managers often don’t have time to carefully read through every detail of your resume, so a resume summary is a great way for them to get a high-level overview of your work history. When brainstorming what to put in your chemistry resume elevator pitch, include your personal strengths as a chemist, or even the types of people you’ve learned to work with (i.e., biostatisticians, pathologists, professors).

What are the top skills you should add to your Clinical Research Associate resume?

On top Clinical Research Associate resumes, skills like Good Clinical Practice (GCP), Clinical Monitoring, Clinical Trial Management System (CTMS), Electronic Data Capture (EDC), Clinical Trials, Clinical Research, Protocol and Clinical Development appear most often. Depending on the exact role you're applying to, skills like Clinical Research Associates, Regulatory Submissions, Clinical Site Monitoring, Oncology Clinical Research and CRO Management can also be effective keywords to include on your resume.

Target your Resume to a Job Description

While the keywords above are a good indication of what skills you need on your resume, you should try to find additional keywords that are specific to the job. To do this, use the free Targeted Resume tool. It analyzes the job you are applying to and finds the most important keywords you need on your resume. It is personalized to your resume, and is the best way to ensure your resume will pass the automated resume filters. Start targeting your resume

Most resumes get auto-rejected because of small, simple errors. These errors are easy to miss but can be costly in your job search. If you want to make sure your resume is error-free, upload it to Score My Resume for a free resume review. You'll get a score so you know where your resume stands, as well as actionable feedback to improve it. Get a free resume review

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Home » Blog » CRA Skills & Education Requirements

CRA Skills & Education Requirements

Table of Contents

The CRA career path requires significant investment in education and skills in order for one to be successful. Let’s break down the education requirements and CRA skills you’ll need to land a job and progress in your career as a CRA.

Education for CRAs

Although there are no exact rules, the general educational requirement for a CRA role is typically a Bachelor of Science (BS) or a Bachelor of Art (BA) degree in life sciences, medical sciences, or healthcare related field such as nursing.

An advanced degree is not required, but it can be helpful for career progression as a CRA. An advanced degree can help you stand out from the crowd if you plan on taking on a leadership role, or if you are planning on being highly specialized in your clinical research field.

Certification and Training

Getting certified is another way to show you can go the extra mile to potential employers. Although not always required, certification can be very advantageous in some situations. Common certifications include Certified Clinical Research Associate (CCRA) from the Association of Clinical Research Professionals (ACRP) and Certified Clinical Research Professional (CCRP) from the Society of Clinical Research Associates (SOCRA).

On the job training goes hand in hand with some of the CRA skills mentioned below. Entry-level CRAs typically undergo a period of training under the supervision of experienced professionals. This training includes learning specific protocols, regulatory requirements, and detailed reporting procedures.

CRAs perform variety of functions related to the effective execution of clinical trials. As different functions require different skill sets, below are some skills that can be helpful in a CRA’s job performance:

• Excellent communication skills (both written and oral) This is important as CRAs work with clinical trial sites (Principal Investigator and staff), regulatory review boards, key opinion leaders (KOLs), and colleagues.
• Ability to motivate and train others This goes along with the communication skills. CRAs will need to train and monitor the progress of clinical trial conduct at different clinical sites.
• Attention to detail CRAs will need to be able to see mistakes and identify incorrect trial data / results. The work also involves documentation and recording of information. Detail oriented skills is critical to the monitoring work to ensure that clinical trial results are recorded appropriately and are accurate based on source data on medical records.
• Problem solving skills Unexpected events and issues often will come up throughout different phases of clinical trial. CRAs are the main contact for all the issues that may come up. Thus, CRAs should maintain flexibility and positive approach toward unexpected issues.
• Multi-tasking, time management, and organizational skills Multi-tasking skills are essential as CRAs are often handle different tasks at the same time. Time management skills are the key to effective work schedule arrangement in order to avoid overload. Organizational skills will help CRAs when working with stringent record keeping and regulatory requirements from regulatory bodies that regulate clinical trials.
• Analytical CRA skills CRAs will need to possess the ability to analyze clinical data and to interpret and understand different regulatory requirements.
• Ability to travel Although travel can vary depending on the type of position, CRAs are expected to travel to clinical sites as needed. Ability to handle travel both domestically and internationally is one of the skills needed for CRAs.
• Knowledge of good clinical practice (GCP) & FDA Code of Federal Regulations ( 21 CFR 11 , 50 , 56 , 312 , 812 , 45 CFR 46 ) These are some of the documents that govern clinical trial conduct. Familiarity with these documents is essential. If you are new to the industry, they can be learned.

Ernie Sakchalathorn

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Clinical Researcher

How the Pandemic Has Magnified the Importance of Soft Skills for Clinical Research Associates

Clinical Researcher November 16, 2021

Clinical Researcher—November 2021 (Volume 35, Issue 8)

PEER REVIEWED

Agnieszka Finlayson, MSc, MA

Before the COVID-19 pandemic, soft skills for use in clinical trial environments were already challenged,{1} with each clinical research associate (CRA) left to his or her own devices in forming and improving upon these skills. CRAs hardly, if ever, received formal training on what soft skills are needed to thrive in this demanding role; only with time and experience could they, like anyone else, strengthen their communication practices.

Without formal training, the most natural way for humans to communicate effectively is in person, which is what traveling CRAs relied upon. However, during lockdown, any sort of face-to-face communication was restricted. CRAs could communicate with busy sites only through digital means. Site staff still needed support and training, but CRAs no longer had the luxury of doing this while being present physically for utilizing both verbal and non-verbal cues to build rapport with site staff.

As with other industries, the clinical research enterprise turned to online tools to get important work done in pandemic conditions. Teleconferences became video calls, onsite visits became remote visits, and face-to-face conversation became e-mails. As these were not proper substitutes for the lack of physical interaction, the difficulty that CRAs already faced with training and motivating site staff was intensified.

While CRAs are intensively trained in hard skills such as source data verification or investigational medicinal product accountability, as well as the systems required to support their work on the study, soft skills are usually ignored. It was as if forgotten that a CRA’s role is effectively dealing with people—be they site staff, fellow CRAs, or vendors. The time for CRAs to start focusing on their soft skills has already passed us; however, the importance of not doing it has never been laid as bare as it is now.

The author of this article believes that post-pandemic online courses are a perfect medium to teach any required soft skills, as has been written about by others in Clinical Researcher .{2} By being better at communicating and dealing with people, CRAs (as with everyone involved in clinical trials) can not only improve the quality and efficiency of their studies, but they can improve the quality and efficiency of their lives.

What are Soft Skills?

Soft skills are human skills,{3} as Simon Sinek puts it. They are a combination of various capabilities and ways in which we interact with others. Empathy, communication, listening, and general “people skills” are all examples of soft skills. They are the qualities which distinguish us from each other and from any machine or a robot.

Through an optimal use of these skills, we can connect with other people. We can understand what is important to others and, through this, we can communicate in a way that motivates and inspires them. Soft skills can be improved with training, practice, and time.

The opposite of soft skills are hard skills—the things you need to know in order to do your job. These are normally industry- and job-specific skills and, as is the case with CRAs, are also attained through training, practice, and time.

How Do Soft Skills Apply to the CRA Role?

CRAs work in a highly regulated yet dynamic environment. Functions around CRAs may be under various pressures while trying to meet conflicting deadlines. CRAs have to be empathetic to the people they work with to keep doing their work without being demotivated or taking things personally. If site staff are stressed and struggling and CRAs cannot empathize with them, it will be almost impossible for CRAs to build great collaborative relationships{4} with sites.

Communication

CRAs are a liaison between the sponsor and the site staff. Study management may sometimes need to achieve aggressive deadlines and inadvertently may put pressure on CRAs. However, site staff need to stay focused and motivated. It is therefore necessary for CRAs to communicate urgency to, and help set priorities for, site staff, but at the same time not induce panic or stress because that would be counterproductive.

Each site is different in what support it needs from CRAs to do the best work. For instance, some site staff like phone call reminders to do something, others prefer e-mail reminders, while others get offended by either. Some people require e-mails that are quick to read and a list of tasks that are arranged by priority, while others require explicit and detailed instructions.

CRAs must tailor their approach to each individual. Consequently, CRAs have to be able to listen carefully to all the messages that site staff convey, both verbally and non-verbally. CRAs have to look for cues about their site’s level of workload in order to have the site prepared for a deadline and be confident it can meet that target.

CRAs are in a unique position of having to motivate their site staff and create effective collaboration without having any mandate over them. Without soft skills, this will simply not be possible. Site staff are usually allocated to multiple studies and CRAs need to stay on top of them—no matter how many other pots they are stirring—for the good of their particular sponsor’s study. CRAs can help site staff be effective, efficient, and motivated to do a high-quality job. This is a key area where CRAs with strong soft skills will prevail over those with weaker soft skills.

Before the Pandemic

Normally, people exercise their soft skills face-to-face. When next to another human being, we use our social skills and emotional intelligence to “read” people and respond appropriately in order to build rapport and communicate effectively. Once a relationship with a study team or site staff is established in person, that usually increases collaboration.

When CRAs or site staff find themselves inevitably under pressure, they will be more forgiving due to the rapport that has already been established. Because site staff have met their CRA in person, they will trust them in the future and vice versa.

When CRAs join a new company, such as a contract research organization (CRO), they get a lot of training. However, a vast majority of this training is about hard skills and technical aspects of the job: the tenets of Good Clinical Practice, creating and following standard operating procedures and study-specific procedures, etc. As CRAs develop and gain more experience, they are assigned to more complex studies and receive more study-specific training. CRAs become well-trained and well-prepared for the complexity posed by the indications and protocols they are working on, but only on a technical level.

Unfortunately, at no time are CRAs provided with extensive soft skills training, if they are provided with any at all. Often, CRAs need to rely on their own wits and support and advice from other CRAs through informal networks in order to get their tasks completed. This state of affairs is tolerated because at the end of the day, CRAs meet their goals and it is physical interactions that help get them over the line.

During the Pandemic

The COVID-19 pandemic brings challenges at every level for everyone. Lockdowns, travel bans, and social distancing each bring their own set of difficulties that CRAs, like anyone else, must overcome. In-person interaction, with all its fragile elements that were previously done subconsciously and taken for granted, is severely restricted.

CRAs can no longer attend site visits. Everything moves online and is done remotely. In addition, CRAs have to train site staff in this new way of doing things. Soft skills that were already lagging behind hard skills become even more essential. Across the industry, new tools and new processes are quickly adopted, causing friction and hassle in what was already a fragile network of relationships. These new tools bring with them new challenges.

Zoom Etiquette

Video conferencing comes to the fore to replace face-to-face meetings. Even though this mode of communication is not exactly new, the extent to which we are currently using it is unprecedented. Tools like Zoom, Teams, and Skype, all video-conferencing interfaces, become part of our human interaction with anyone who does not live in our household. Out of all the available video conferencing tools, Zoom is probably the most famous for both the right and wrong reasons. Therefore, this article will focus on Zoom as an example of all similar tools.

Because communicating face to face is nothing like communicating on Zoom, we needed some guidelines to convey our message via this medium as accurately as possible. Collectively and informally, participants in Zoom calls created a set of rules to communicate online effectively called Zoom etiquette. While Zoom etiquette is difficult to define and out of scope of this article, one key example is through eye contact.

When participating in a video call, each participant has to make a choice between looking directly into the camera (to give the other participants the illusion of having a real physical conversation) or looking at the monitor (to get non-verbal cues via their video streams). This means that it is now impossible to have a conversation and hold eye contact at the same time.

Any video conversation will always lack the synchrony of a conversation as you may miss facial expressions when looking at the camera, or other participants may miss your gestures as they are looking at their camera while mimicking physical eye contact (instead of looking at their monitor).

Zoom etiquette rules come about to lower expectations and tell participants that even if others are not “looking” at us through their cameras, it is because they are paying attention to what we say, hence looking at their monitor. This is particularly true if people’s setups mean their cameras are out of position relative to their monitors.

Through these video calls, soft skills are “working overtime.” The disconnect between video and face to face communication needs to be compensated with soft skills in order to foster a positive human-to-human interaction. To top it all off, the psychological reward that we would normally receive from physical communication which would make us alert is not really there.{5} This leads to Zoom fatigue.

Zoom Fatigue

Zoom fatigue is a term used to describe the tiredness, anxiety, or worry resulting from overusing virtual platforms. Video conferences are mentally exhausting.{6} Sensory overload may also be playing a part. We are now using our eyes, ears, and facial expressions in disjointed ways which we are not used to.

Staring at a monitor all day is tiring. The lack of movement and the required high level of focus all come together to exhaust us. On the top of it, we are forced to “overuse” our soft skills, foster attentiveness while on camera, and we have to do all this without the natural energy boost from a physical conversation.

Zoom fatigue can be contagious. When you are speaking to somebody who appears tired, that tiredness can transfer to you. If it is your first call for the day and their sixth, you will know it and start feeling their fatigue, too. This, unfortunately, is the flip side of being an empathetic CRA.

Languishing

There is also an emotional, long-term effect of the pandemic. A feeling of stagnation and emptiness that a lot of us are feeling is known as languishing. It is claimed to be the most dominant emotion of 2021.{7} Adam Grant explains languishing as an emotion that lies between depression and flourishing. Critically, we need soft skills to combat it—we need to feel connected to others, to be a part of a community.

CRAs are in a great position here because of the meaningful nature of the work they do. As an industry, we need to keep reminding ourselves of the good we are collectively doing and stay focused on achieving our goals. We need to make sure that we remember the bigger picture of getting the medicine to market and the patients who will benefit.

After the Pandemic

What will become of the skills and solutions that we used during the pandemic when the dust settles and we reach a “new normal”? It is hard to think that everything we learned during the pandemic (e.g., communicating through video conferencing, remote working, and online training) will fade away as our state of practice reverts to how it was before.

A balance of the “old” and “new” must be the way forward. In this, the “old” will include tasks such as making traditional physical site visits when required or attending investigator meetings and seeing everyone involved in a study face to face. Meanwhile, the “new” may include further remote or flexible working, more remote monitoring visits than prior to the pandemic, and an appreciation of when to use video conferencing.

Ultimately, we will all organize our time differently and start prioritizing human connections above all. In-person interaction and time spent with family and friends will prevail over superficial interactions.

If these auxiliary interactions can be permanently shifted online, much like during lockdown, we can gain more valuable time for ourselves. Furthermore, if more “static” content can be consumed via online pre-recorded media, then we can further gain time and flexibility by eliminating commutes and pausing or playing back content as needed.

Time to Appreciate Soft Skills

No matter what the outcome is after the pandemic has subsided, what has been made clear is that our current lack of focus on soft skills in general, let alone their training and development, is not a sustainable position. We managed to stumble our way through awkward Zoom calls and e-mails without context or tone of voice. These lessons will not go away quickly, nor will the repercussions of not being prepared.

Soft skills training and development must go hand-in-hand with hard skills training and development. By ignoring effectively half of a CRA’s role, pharmaceutical companies and CROs are only harming themselves, their studies, and ultimately the investigational medicinal product.

The Right Tool for the Job

One of the instrumental methods that CRAs, and indeed anyone else in clinical research, should be utilizing going forward is the medium of online courses. We have collectively enjoyed not losing time on commutes or long travel to training sessions at the office where in-person training can have negligible results.

Instead, taking our lessons learned from the pandemic, we can shift all of this online. Online courses allow CRAs to complete them at their leisure, working in-between their personal and professional needs. As new training is made available, it is simply posted online for CRAs to complete. Much like hard skills training, more advanced soft skills courses can be made available to CRAs as they progress in their careers.

While it took a global pandemic to shake the status quo, ultimately this disruption will be of benefit to the industry as a whole. CROs and pharmaceutical companies massively benefit by having CRAs trained in both hard and soft skills, as this will lead to having more efficient sites, reduced study costs (compared to before the pandemic), and higher quality studies with the potential of going to market sooner. Meanwhile, CRAs are more likely to be happier with their roles leading to lower churn and creating an upwards spiral of skill and experience. Ultimately, a healthy work-life balance for CRAs (and indeed all clinical research professionals) means better studies and better results.

• https://www.youtube.com/watch?v=o9uzJ0LgvT0&t=201s
• https://www.forbes.com/sites/amyblaschka/2019/02/19/the-soft-skill-gary-vaynerchuk-simon-sinek-and-oprah-winfrey-say-is-crucial-for-leaders/?sh=28ca76d84e9b
• https://www.psychiatrictimes.com/view/psychological-exploration-zoom-fatigue
• https://www.psychologytoday.com/us/blog/the-desk-the-mental-health-lawyer/202005/virtual-platforms-are-helpful-tools-can-add-our-stress
• https://www.nytimes.com/2021/04/19/well/mind/covid-mental-health-languishing.html

Agnieszka Finlayson, MSc, MA, ( [email protected] ) is Founder and Director of the White Wisteria Academy , which focuses on training for clinical research associates and is based in the United Kingdom.

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Clinical Research Associate Job Description

Clinical research associates manage clinical trials and studies pertaining to biotechnological and pharmaceutical products, drugs, and procedures. A clinical research associate, also known as a CRA, conducts research to ensure these products are safe to allow on the market.

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Clinical Research Associate Job Description Template

We are looking for an organized, flexible clinical research associate to oversee clinical trials. The clinical research associate will develop and outline trial protocols, establish trial sites, train site staff, and manage Investigational Product (IP) and trial materials. The clinical research associate will manage multiple aspects of the subjects' welfare. You will conduct regular site visits, generate and distribute internal and external newsletters, prepare final reports, and liaise with interested parties regarding all trial aspects. You will play a leading role in generating and overseeing documentation and records.

To be successful in this role, you should be able to recognize logistical problems and initiate appropriate solutions. Ideal candidates will be detail-oriented, have the ability to multitask, and be able to collaborate with various role players.

Clinical Research Associate Responsibilities:

• Creating and writing trial protocols, and presenting these to the steering committee.
• Identifying, evaluating, and establishing trial sites, and closing sites down on completion of the trial.
• Training site staff on therapeutic areas, protocol requirements, proper source documentation, and case report form completion.
• Liaise with the ethics committee regarding the rights, safety, and well-being of trial subjects.
• Ordering, tracking, and managing IP and trial materials.
• Overseeing and documenting IP dispensing inventory, and reconciliation.
• Protecting subjects’ confidentiality, updating their information, and verifying IP have been dispensed and administered according to protocol.
• Conducting regular site visits, coordinating project meetings, and writing visit reports.
• Implementing action plans for sites not meeting expectations.
• Liaising with regulatory authorities.
• Ensuring compliance with SOPs and local regulations, and ICH and GCP guidelines.
• Other tasks and responsibilities as needed.

Clinical Research Associate Requirements:

• Bachelor’s degree in biological science or a related field.
• 2+ years of experience as a clinical research associate.
• Knowledge of the pharmaceutical industry, terminology, and practices.
• Knowledge of FDA regulations and their practical implementation.
• Strong verbal and written communication skills.
• Proficient computer skills.
• Proficient with Microsoft Office Word, Excel, and PowerPoint.
• Ability to manage and prioritize workload effectively.
• Available to travel extensively and on short notice, and ability to manage travel schedules, such as flight schedules.
• Valid driver’s license, proficient driving skills, own reliable transport, and up-to-date car insurance.

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What are the top skills you need to work in clinical research?

Clinical research is the backbone of the life sciences industry . In fact, the established processes used to accurately trial and research medical, surgical and behavioural intervention are essential to its existence. They allow life science businesses to safely push the boundaries of our understanding and formulate better treatments for everything from the common cold to life-changing illnesses and diseases.

The role of clinical researchers has come into the spotlight in recent years. The Covid-19 pandemic required extensive, comprehensive medical research to be executed faster than ever before . As we continue to face threats of this nature, it is clear that the clinical research space will need more ambitious, highly skilled and innovative professionals to help overcome major challenges.

In this article, we explore six of the most sought-after skills in clinical research.

People skills

We start this list with an often-overlooked skill when it comes to conducting clinical trials. Although you may imagine that clinical research trial professionals spend considerable time working in isolation, in fact, they often find themselves interacting with others.

It is crucial that professionals in this space are able to build strong and long-lasting relationships with trial centre staff and colleagues. Clinical trials always require a range of skills and therefore tend to depend on multiple professionals working together to ensure their smooth running.

A clinical trial manager will also often deal directly with the client, making people skills essential to successful communication and securing ongoing funding for essential research.

Critical thinking

The majority of clinical trials require critical thinking. Most challenges and options tend not to be binary – either yes or no - and instead require clinical research professionals to analyse facts, evidence, observations and arguments to form a judgment on the best options to take.

Professionals that gather information and assess situations as a whole will be assets to clinical research teams. Critical thinking is often a skill that employers look for when filling junior roles such as clinical research-associated jobs, as it is something that will pay dividends right from day one. In fact, critical thinking is often cited as a topmost employable skill in almost every industry.

Change management

Life science has always been fast-moving and unpredictable. Yet the advent of Covid-19 made the industry even more aware that the unknown future may require rapid and wide-reaching changes with very little notice. This is why change management is such an essential skill for those in clinical research careers .

Process improvement

Although clinical trials are often comprehensive in nature, there is always room for improvement. In fact, clinical research professionals typically spend considerable time looking to make improvements in everything from reducing the cost and timespan of trials to improving the quality and reliability of results.

Those with a keen eye for identifying areas where improvement can be made will be seen as highly valuable to customers and employers.

Detail orientation

There are few industries where details are as important as in clinical trials. The difference between picking up on potential inaccuracies or not can literally mean life or death. So, there are also few other careers where those who are detail-orientated can have such a positive impact.

Data analysis

Although as a clinical trial professional you will certainly be relying on a wide range of skills such as people management and process improvement , ultimately the majority share of most roles will involve deep data analysis.

Professionals that can correctly gather, work with and analyse data will thrive in the clinical trial space. Other skills that are valuable in this area include knowledge of data models and an understanding of how to use data analytic tools.

Are you looking for your next opportunity within clinical research?

Clinical trials are an exciting space to start or progress your career. Although you will likely need qualifications in order to apply for roles in this space , the skills you need go far beyond simply holding a degree. Those who possess skills such as people skills, a keen eye for data analysis and change management will thrive in clinical research teams.

If you see yourself developing a career in the clinical research space, you can browse our project management jobs , clinical trial jobs , clinical research associate roles and pharmacovigilance and patient safety roles .

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Clinical Research Associate: A Full Guide on Becoming A CRA

Clinical Research Associate

A complete guide on how to become a clinical research associate.

Over 1.9 million students receive a bachelors of science every year. While a few go on to PhD, Masters, and Medical programs; many are ready to start clinical research certification online to start a career in the frontiers of medical research and patient care.

As a new student applying to the science job market, you may only find internships or recognize that even entry-level science jobs requires 1-2 years of experience. More so, you may realize many of these jobs require intense labor in the lab or just did not meet your expectations for your science degree.

This is why a career as a CRA should be considered with clinical research coordinator training. We train over 500 students each month in clinical research coordinator training and clinical research associate training (depending on prior background).

For those who have always wanted a career in medicine or have a gap year before medical school; Clinical Research Training is the next step to getting a head start in your career.

Because the position is unlike actually working in the lab and more of a management role; you get 1-on-1 connections with physicians and medical staff that can lead to a better application for medical school and other medical careers later on.

Best of all; many of these positions accept remote staff (and some allow you to travel 45-75% with full expenses including travel, accommodation, meals, and other per-dime expenses covered).

Clinical Research Training can help you save money while also increasing your salary. CRA’s with our level of training can expect to make between $6,500-$12,000 a month with an estimated promotion rate of 33% a year: an amount that is uncommon in other science-degree careers.

CCRPS is one of the only major US-based ACCRE, ACCME, ANCC, ACPE, and Transcelerate Biopharma accredited CRA certification courses that accepts students with no prior background for certification. T

his is because our course is thorough and created by Senior CRAs who have been in the field for long enough to understand what you need to know to begin working and applying. The course can be completed in as little as 7 days with dedicated full-day study time.

Clinical Research Associate Certification Qualifications

Foreign Doctors Welcome : A Clinical Research Associate or Coordinator plays a vital role in directing and supervising clinical trials conducted by physicians, nurses, and other science professionals. This career path is particularly attractive to many foreign doctors with completed medical degrees (MBBS) who can utilize their expertise in the US healthcare system by pursuing a CRA career instead of taking the USMLE or repeating residency training. For those interested in coordinating aspects, consider the Clinical Research Coordinator course .

Distinct Skillset : Unlike the traditional medical field you may be familiar with after years of schooling, Clinical Research Associate training provides a distinct and valuable skillset. For comprehensive understanding of Good Clinical Practice, see the ICH-GCP course .

Most Extensive Online Course : Our program goes beyond basic introductions, offering a comprehensive curriculum with over 110 modules – the most extensive Clinical Research Associate course available online. This in-depth training ensures you're well-prepared to secure a coveted CRA position.

Superior Coursework : Securing a CRA role is a strategic career move compared to the limitations of many traditional medical positions. While generic courses abound, we've observed that graduates often struggle due to a lack of substantive content. Our Clinical Research Associate course addresses this gap by providing Senior Clinical Research Associate-level training through 110 intensive modules grounded in the latest scientific principles. For those looking to assist in clinical trials, the Clinical Trials Assistant Training may also be of interest.

Diverse Career Opportunities : This high-demand science-based medical field offers diverse opportunities:

Work in the Private Sector : Pursue a CRA career with renowned pharmaceutical companies like Pfizer. Enhance your skills with the Advanced Clinical Research Project Manager Certification .

Academic Opportunities : Work in the academic sphere at medical schools. Those aiming for higher responsibilities may consider the Advanced Principal Investigator Physician Certification .

Unmatched Flexibility and Knowledge : In addition to our exceptional course content, we boast the largest number of clinical research courses available online, providing you with unmatched flexibility and knowledge. For those interested in safety monitoring of drugs, the Pharmacovigilance Certification and Medical Monitor Certification can enhance your capabilities in these critical areas.

Why Take A CRA Certification Course

 The role of the clinical research associate is to ensure that medical devices, new treatments and new drugs are approved for patients' use.

This field is taken as a certificate program course in many schools. For example, you may find associate degree programs. These programs can be completed in two years and can be offered through both the online and the hybrid formats. Hybrid formats combine both online and on-campus courses together.

If you opt for a fully online program, you can still get an immersive education. Different platforms like emails and discussion boards are used to ensure and promote interaction between the students as well as the lecturers.

Online learning platforms are used to upload the syllabus, course materials, lectures and assignments. Some online programs include field work as part of their requirements, in order for students to gain first hand experience working with clinical trials and patients. Depending on the school, they may have a list of approved clinical research institutes and other facilities. Otherwise, you will have to find a facility for yourself and get the school's approval.

These certificate programs are generally designed for professionals that are already in the medical fields (like medical assistants or nurses) and are interested in moving to the field of clinical research.

They may therefore ask for a copy of your CV or resumé or they may ask for a letter from your employers to verify that you have the needed medical experience. Some programs may require just an undergraduate degree in a medical science or life science related field.

Clinical research associates are trained to assist clinical researchers and investigators in the coordination, administration and management of clinical trials.

During this training, different courses will be taught revolving around subjects like safety procedures, subject recruitment, regulatory requirements, drug development, accountability, trial management, medical terminology etc.

The importance of the role of the clinical research associate means that companies that conduct clinical trials are usually very selective. The need to comply with strict regulations often inform their decision when making a choice of their clinical research associate. It is therefore very difficult to get a job as a clinical research associate without previous experience in clinical trials.

Many companies require around at least two years experience in clinical monitoring as a clinical project assistant or clinical trial administrator before considering applicants for this important role.

In applying for the post of a clinical research associate , ensure that you read the job description and indicate or highlights the relevant experience on your curriculum vitae. Your cover letter should be specific to the company you're applying to.

Do not use a one-for-all cover letter. Personalize your cover letter to each company and highlight the skills that fit the specific requirements of the role. Not all companies advertise their vacancies, so you can try to find out about other unadvertised vacancies, you might increase your chances.

Further certification can enhance your resume such as the ACCRE accredited CRA program which contains 110 learning modules for Clinical Research Associate Training and Placement

The Best CRA Certification Course For Entry-Levels

There is a huge shortage of well-trained CRAs, but many companies are reluctant to hire untrained entry-level clinical monitors because of patient and trial safety. Because of this, even the beginner entry-level jobs require certification or training.

Our program is considered one of the top clinical research graduate programs online. Most courses provide very light training that may look good because of the company names, but alone is not sufficient to pass the interview rounds a company conducts.

Because our modules are prepared help even Senior Clinical Research Associates, we find more of our students with no background quickly passing their interview rounds.

CCRPS Course covers double to triple the amount of course content than other courses. While many courses are simply 5-20 simple interactive modules, our course covers 140 dense modules in thorough detail.

After each session, students can ask their questions privately with the course instructor, all of whom have 15+ years of CRA experience.

Currently, 82% of our students are hired within the first month of taking the course. Students with limited background or those looking to gain extra experience are offered a remote internship of up to 6 months during the time they are interviewing.

This advantage allows many students with limited experience to get hired with a higher paying job than previously offered.

While a majority of our students are physicians, a majority of the CRA workforce are Science Grads and Nurses. nonetheless, we train all students at a Senior CRA level regardless of background because clinical research monitoring is vastly different from any lab or science course you may have taken.

Clinical research associates are given the protocol of a study including all medical protocol that must be followed but because they do not diagnose or treat. Medical knowledge is supplemental but not sufficient in this career path.

This is the main reason why our Clinical Research Training includes all possible scenarios you may face at the protocol and guideline level in your future company.

How To Get Experience For Clinical Research Associate Jobs

CCRPS, like other educational institutes, is only associated with educating and certifying clinical research professionals so we do not provide job placement. We want to make sure you apply with your best foot forward. Below are links we readily refer to graduates who are looking for job support. Having a great CV and cover letter are essential to applying for jobs. Recruiters are paid by the company which hires you and thus are free for searching employees. Be realistic but also be driven. Make sure you get continue reaching out until you get a true rejection from any job you apply to as they may never have seen your application if you received no response.

Clinical Research Job Advising: Kunal at ClinicalTrialPodcast

Free Resume Review: TopCV TopCV provides a free review and feedback for your current resume.

Resume Distribution: ResumeRabbit Resume rabbit distributes your resume to 60 job posting sites.

Clinical Research Recruiters: I-Recruit I-Recruit distributes your resume to clinical research recruiters.

Clinical Research Job Bulletin: Indeed Indeed usually provides the most uptodate job bulletin for clinical research jobs

Always use a cover letter specific for the company and job when applying if you are not using a recruiter.

The ICH-GCP in Clinical Research

Regardless of the type of clinical research or function of an IP being tested, it is important that clinical research should meet two critical criteria:

The clinical research process should respect the rights, freedom and dignity of tested patients (human participants).

Data from the clinical research process should be accurately collected, safely stored, rigorously scrutinized and correctly interpreted.

One way to ensure that these requirements are met is to follow a set of internationally recognized and accepted standards for clinical research. 

Most countries across the world today follow ICH-GCP, that is, International Committee for Harmonization of Good Clinical Practice guidelines in conducting clinical research on human participants7.

The ICH-GCP outlines procedures and precautions that are essential in order to protect the safety and wellbeing of human research participants during clinical research, and to ensure the integrity of data from clinical research studies.

In the USA, clinical studies are required to comply with the FDA Guidance for Good Clinical Practice, outlined in a document titled ‘E6(R2) Good Clinical Practice: Integrated Addendum to E6(R1)’8.

In the USA, clinical studies are required to comply with the FDA Guidance for Good Clinical Practice, outlined in a document titled ‘E6(R2) Good Clinical Practice: Integrated Addendum to E6(R1)’8.z

Qualifications and Qualities of a CRA

According to the International Accrediting Organization for Clinical Research (IAOCR), candidates for CRA positions usually hold either a biological science degree, or one in medicine or nursing10. 

The New Scientist recommends that aspiring CRAs should possess a good working knowledge of one or more of the following subjects – anatomy, biology, biochemistry, chemistry, immunology, microbiology, pharmacology, physiology or toxicology11.

In addition to a background in medical or life sciences, a CRA is required to have a good grasp of data management, including Electronic Data Capture (EDC), data analytics and reporting12.

Sketching the CRA work profile, the authors Diane St. Germain and Marjorie Good state that CRAs are the ones who scrutinize clinical study data most closely from start to finish—as a result, they are often the first to notice critical patterns and interesting trends, and to report these to the research team as well as to the CRO13.

Equally if not more importantly, a CRA must possess a high level of emotional and interpersonal savvy. This is a crucial area, since a CRA’s success hin ges upon his/her ability to elicit the best from team members, in terms of both performance and probity. 

Core Competency Framework for CRAs

To illustrate, the ACRP’s ‘Core Competency

Framework for Clinical Study Monitoring’

requires that a CRA should be able to identify

and correct compliance violations at a study

site. The CRA must not only bring such

violations to the attention of site staff, s/he

must induce them to take corrective action,

as well as reporting the matter and even

escalating it, where necessary14.

The table below summarizes the ideal

competencies of a CRA, and provides

insights on how each ability contributes to

the CRA’s performance.

CRA Career Path

In the past, CRA positions were often filled by individuals with medical or nursing backgrounds, with little thought given to their lack of research training15. As awareness grew about the importance of research experience for a CRA, employers began preferring those with years of experience in clinical research settings, such as Clinical Trials Assistants (CTAs) and Clinical Research Coordinators (CRCs)16.

However, in recent years, the focus has shifted once again from a tenure-based mindset to a skills-based evaluation17. In part, this change has been brought about by the growth in professional courses and training programs in the field. 

For instance, many leading US Universities today offer master’s programs in clinical research18. In addition, there are some widely recognized certification programs for clinical research associates, such as those offered by the ACRP19 and the Society of Clinical Research Associates (SOCRA) 20.

Note: You must already be working as a CRA to qualify for the ACRP and SOCRA certification programs.

A Toe in the Door: CRA Certification for a Non-CRA

By this point, you might be wondering, “I have no research experience… I’ve never worked as a Clinical Trials Assistant (CTA) or a s a Clinical Research Coordinator (CRC). Nor do I have a degree in Clinical Research. Can I still become a CRA?”

The simple answer is, yes, you can.

You might be a life sciences graduate looking for a lucrative career in the pharmaceutical or biotechnology sectors. Or, you’re excited by a career in research, but unsure whether the drudgery of a Ph.D. is your thing.

Maybe you’re just looking for a job that represents a great option for someone with your combo of science background plus detail-orientedness.

Whichever of these descriptions best applies to you, a career as a Clinical Research Associate could be exactly right for you.

With the right training, you can be recruited directly to a Clinical Research Associate position, even without a background in clinical research.

So, what kind of training will help me break through the ‘experience’ barrier and land a job as a CRA?

As you’ve already gathered from the table, the skill-set required to be a successful CRA is pretty extensive.

Aside from an in-depth knowledge of scientific and medical concepts and principles, a CRA must have a sound grasp of medical research regulatory requirements, a penchant for being thorough and systematic, as well as a knack for coordinating and managing people with diverse skills, roles and backgrounds.

To our knowledge, CCRPC’s ‘Advanced Clinical Research Associate Certification’ (ACRAC) is one of a kind: The ACRAC is the only multi-accredited* certification program in the US that offers the kind of exhaustive as well as intensive training that equips candidates from a non-clinical background with the abilities and competencies that make a good CRA.

Best of all? The ACRAC is open to fresh graduates holding a B.S. degree in any of the life sciences, with no requirement for prior exposure or experience in clinical research.

*The ACRAC program offered by CCRPC is accredited to ACCRE (Accreditation Council for Clinical Research & Education), ACCME (Accreditation Council for Continuing Medical Education), ACPE (Accreditation Council for Pharmacy Education), ANCC (A merican Nurses Credentialing Center), as well as Transcelerate Biopharma.

Training to be a CRA through CCRPS ACRAC

The ACRAC program includes over 100 course modules that cover all the important knowledge domains and skill-sets required by a CRA.

Designed for a total study time of approximately 250 hours, this training program can be completed at your own pace, or, for those able to dedicate the whole day to study, in as little as two to three weeks.

Starting with a broad overview of clinical research jargon and terminology, the course walks students through the principles of Good Clinical Practice, familiarizing you with the relevant sections of the ICH-GCP and the FDA’s E6(R2).

The program places particular emphasis on ethical practices in research with vulnerable populations.

Students going through the ACRAC are trained in all major aspects of designing a Clinical Trial Protocol in keeping with the Code of Federal Regulations (CFR).

They additionally learn the steps involved in the IRB/IEC approvals process and how to prepare required documents.

Finally, students become aware of the importance of pharmacovigilance and the regulatory process for new drug testing.

A major chunk of the ACRAC certification centers around equipping the CRA for day-to-day responsibilities, such as different types of site visits – preliminary (Site Qualification), preparatory (Site Initiation) and progress monitoring visits (Routine Monitoring).

Crucially, the ACRAC covers essential documentation such as the Case Report Form and Trial Master File, as well as electronic data capture (EDC) and remote monitoring systems.

A vital component of the training program involves empowering students to tackle challenging situations.

For a CRA, these include identifying protocol deviations and violations, and recognizing as well as reporting research fraud and ethical misconduct.

In addition to its comprehensive coverage, the ACRAC certification offers the great advantage of including 17.5 CME credits – that is, course credits that count towards ‘Continuing Medical Education’.

These credits can be used by individuals desiring to further their education and/or careers in healthcare-related fields, including medicine, nursing, pharmacy and research.

Clinical Research Associate Training

Get ahead in clinical research with advanced accredited online CRA certification for $450. Demo our on-demand course below.

Clinical Research Associate Certification

Advanced clinical research associate certification (acrac).

Chapter 1: Introduction

This chapter orients you to the concept of Continuing Medical Education (CME) and outlines how the CCRPS CRA program contents meets AMA requirements for CME. Given that, across the US, physician practitioners are required to complete between 20 and 50 hours of CME credits yearly, the ACCME-accredited CCRPS CRA course can be used not only to build knowledge and skills in the field of clinical trial management, but also to further a successful medical career. Additionally, the introductory chapter introduces you to the clinical terminology and abbreviations commonly encountered in clinical research, for example, Investigational Product (IP), Good Clinical Practice (GCP), Institutional Review Board (IRB) and so on. 

Chapter 2: Roles and Relationships in Clinical Trials

The unit presents the foundational background to beginning and building a career as a clinical research associate (CRA). As you know, a CRA plays a critical role in setting up as well as monitoring the clinical trials process for an investigational product or IP – a medical drug or device under development. In this unit, you will learn how a CRA interacts with other stakeholders, including the Clinical Research Organization (CRO) or Sponsor of the clinical trials, the Principal Investigator (PI) as well as other research site staff, the trials monitoring team including the Clinical Research Coordinator (CRC),other CRAs and the Data Safety Monitoring Board (DSMB), as well as the research ethics committee (Institutional Review Board or IRB).

Chapter 3: Sponsor and Investigator Roles

In this unit, you will gain insight into the ICH-GCP guidelines, particularly addendum E6, sections 2 through 5, which outline procedures and precautions essential for protecting the safety and wellbeing of human research participants during clinical research. These include guidelines for obtaining informed consent from human subjects, maintenance of trial records, reporting of compliance, safety and research progress, as well as procedures for suspension or termination of the trials process. The chapter familiarizes you with the critical importance of monitoring for Adverse Events (AEs), including types of AEs and regulations for documentation and reporting.

Chapter 4: Clinical Trial Design

In this chapter, you will acquire insight into the different phases of the clinical trials process, from the pre-clinical phase through Phases 0 to 4 of clinical testing. The unit will familiarize you with important concepts of clinical trials, such as the structure and goals of each phase of clinical trials, approaches to dosing, toxicology of pharmaceutical products, in vitro and in vivo testing, dose escalation and so on. Finally, the chapter reviews the FDA’s drug approval process.

Chapter 5: ICH-GCP – Overview

The chapter dives deep into GCP, including a review of the history of medical research leading up to the ICH-GCP. The unit covers all four QSEM categories of the guidelines for ensuring Quality, Safety and Efficacy of the IP, as well as  Multidisciplinary guidelines (mainly pertaining to documentation and electronic data safety standards). In addition, the chapter includes an overview of MedDRA software that provides a standardized system of terminology and notation for documenting clinical research, as well as principles of budgeting for clinical trials.

Chapter 6: Ethical Research in Vulnerable Populations

The unit provides a detailed walk-through of the regulations and compliance requirements for conducting clinical trials with human subjects who meet the definition of a ‘vulnerable population’, including pregnant women and fetuses, children, mentally incapacitated individuals (those with cognitive functioning impaired by neurolopsychological conditions or chronic substance abuse), as well as prisoners. You will acquire familiarity with the challenges of research in such populations, including the requirement for parental consent, fair but not excessive incentive, justifiable deception or incomplete disclosure, coercive practices and so forth.

Chapter 7: Adverse Events

Through this module, you will gain a bird’s eye view of the protocol for documenting, reporting and responding to AEs or adverse events during the clinical trials process. The unit covers concepts such as expectedness, severity and seriousness of AEs, Adverse Drug Reactions (ADRs) as a sub-category of AEs, Investigational New Drug or IND reports, causality analysis for AEs and so on. In addition, the chapter reviews the responsibilities of both research sponsors as well as IRBs in sharing AE information with subjects. 

Chapter 8: Clinical Trial Protocol

The chapter provides an in-depth tutorial on the structure and elements of a CTP or clinical trial protocol, as well as guidelines on writing a CTP. Important concepts reviewed include study Risk Benefit Analysis (RBA), study sample statistics (sample size, statistical power, plan for data analysis), risk management and study administration. Additionally, the module covers concepts central to study sample selection, addressing inclusion and exclusion criteria, especially safety and ethics considerations in sampling. 

Chapter 9: Protocol Deviations and Violations

Through this unit, you will gain familiarity with the many potential causes of protocol deviations and violations, learning to distinguish between minor (deviations) and major departures or violations of protocol. Content provides understanding of the most commonly occurring violations, including both minor (off-schedule subject assessments, subjects’ use of prohibited drugs, and so on) as well as major violations (failure to obtain informed consent, failure to report AEs and so forth). Further, the chapter reviews principles for reporting protocol deviations, IRB approval for planned deviations and related concepts. 

Chapter 10: IRB and DSMB

This chapter briefly reviews the history of IRBs and examines the principles guiding IRB decision-making. In addition, the unit discusses recent developments in compliance, including sIRB (single IRB) and SmartIRB for institutions that are part of the CTSA (Clinical and Translational Science Awards). The bulk of this module dives into the categories of IRB review, including full board and expedited review, examining criteria for review exemption such as educational or purely behavioral research, as well as studies collecting identifiable data, surveys and interviews.   

Chapter 11: Review Questions

The module provides a self-assessment tool by including questions that review the content covered in previous chapters. The set of 71 questions examines all aspects of ICH-GCP previously discussed.

Chapter 12: Site Monitoring Visits

In this module, an overview is provided of the different types of site monitoring visits, including site selection or qualification visit, study initiation visit, routine or progress monitoring visit, as well as study termination or close-out visit. Important concepts discussed include pre-qualification preparations and site feasibility assessment as well as study monitoring criteria (data omission, incorrect entries, inaccurate calculations, documentation of corrections and so on). For each type of site monitoring visit, the chapter reviews relevant documentation.

Chapter 13: Site Qualification Visit (SQV)

The chapter gives an in-depth understanding of the stages and steps involved in selecting a study site. Elements reviewed within the module include the process of investigator selection and criteria for site evaluation (the four P’s: Patient, Protocol, Performance, Profit). Importantly, the module reviews the most common errors in feasibility assessment, including overestimation of sample availability at site, selection of site staff with low motivation, poor-performing sites owing to high competition for personnel and resources (for example, owing to multiple studies running on a single site), and so on.  

Chapter 14: Site Initiation Visit (SIV)

The module dives into the details of an SIV or site initiation visit. You will review the procedure for pre-SIV preparation, including filing for IRB and other necessary approvals, permits and licenses. Additionally, the chapter examines elements of the SIV agenda, mainly orientation and training of site staff, creation of important study-related documents such as the Trial Master File (TMF) and post-SIV filing of compliance documents such as FDA form 1572 and Financial Disclosure Form (FDF) for relevant site personnel. 

Chapter 15: Routine Monitoring Visit (RMV)

In this unit, the elements of a routine or periodic monitoring visit are discussed in detail. You will become familiar with the agenda of an RMV, which prioritizes receiving updates on AEs from site staff (incidence, documentation, seriousness and so on), as well as oversight of the overall progress of trials. The chapter covers different approaches to site monitoring, contrasting traditional (full-scale) monitoring with risk-based monitoring (RBM), as well as comparing on-site monitoring with remote monitoring. A crucial concept addressed by the unit is Source Data Verification (SDV), which is central to obtaining meaningful, high-quality data from clinical trials.

Chapter 16: Site Close-Out Visit (SCOV)

The module gives you a comprehensive overview of the protocol and procedures involved in terminating or closing out a trial site. Aspects covered in the chapter include pre-SCOV preparations such as IRB notification and schedule coordination among site staff (PI, other investigators, medical staff) and monitoring team (CRC, CRAs and so on), agenda for an SCOV – drug inventory management, database verification and lockdown, subject intimation and completion of all subject-related documents, staff-related documentation as well as other administrative tasks including close-out report compilation.

Chapter 17: Tools for Monitoring Visits

This unit outlines a host of tips and tools that can help a CRA in successfully tackling the complex process of monitoring clinical trials. The chapter lists numerous physical accessories you can use for effective monitoring, including scheduling and calculation aids, ready reckoners for drug information and medical terminology, as well as document templates to speed up the process of obtaining trial updates while also serving as checklists for the site visit agenda. Additionally, the unit highlights helpful strategies that a CRA can use to ensure that site visits go smoothly, from travel advice to team-building suggestions. 

Chapter 18: Audit and Inspections

The module deals with one of the most crucial and often most feared aspects of a CRA’s career – audits and inspections by the CRO (sponsor), FDA or other regulatory authority. Starting from the basic distinction between an audit and an inspection, the chapter covers in detail the protocols for both audits and inspections. Crucially, the chapter will enable you to grasp the difference between a routine audit/ inspection and a ‘for-cause’ audit/ inspection. Further, it lays out the sequence of an FDA inspection in full (including a detailed walk-through of the FDA BIMO or Biomedical Research Monitoring Program inspection), and provides important guidelines on the do’s and dont’s for CRAs during an audit/ inspection, such as the critical ‘3 to 5 minute rule’. You will acquire familiarity with important audit and inspection-related documents such as FDA Form 482 (Notice of Inspection) and Form 483 (Notice of Observation) as well as the Establishment Inspection Report (EIR) prepared by the auditor/ inspector. Finally, you will gain insight into the classes of observations provided in an EIR, including NAI (no action indicated), VAI (voluntary action indicated) and OAI (official action indicated)—the last is commonly termed an ‘FDA warning letter’.

Chapter 19: Review Questions

The unit contains a self-assessment tool comprising 65 questions that review the content covered in previous chapters, as well as a 15-item quiz. Questions and quiz examine all aspects of clinical trial quality monitoring, including monitoring visits, tools as well as audits and inspections.

Chapter 20: SDV and Informed Consent

In this chapter, the ICH-GCP section 4.8 guidelines on obtaining informed consent from subjects are discussed in detail, highlighting the need for using non-technical language, transparent delineation of risks, consent without undue influence, obtaining consent (and assent) from minors and their Legally Acceptable Representatives (LARs), as well as consent from non-English speakers and sedated subjects. The chapter additionally covers important aspects of Source Data Verification (SDV) with respect to electronic as well as paper-based medical records, and highlights the central goal of SDV, which is to conform to ICH-GCP requirements that subject trial data (as recorded in Case Report Forms or CRFs) must correspond to source data (previous medical records).

Chapter 21: Case Report Form

The module provides an in-depth tutorial on the structure and elements of a Case Report Form or CRF, including the different forms for PI verification, subject enrollment, eligibility and randomization, medical history, physical examination and laboratory data, compliance, adverse events and so on. In addition, the chapter outlines important data notation rules, such as the use of accepted acronyms (‘ND’ for missing data and ‘UNK’ for unknown information, MM-DD-YY format, time-stamp data and so forth), as well as guidelines for the design of CRFs (such as consistency of notation, avoidance of data fields that can be computed and of duplicate data fields and so on).

Chapter 22: Quality Control and Safety

Within this unit, you will learn the central concepts of Quality Control (QC) in the context of clinical trials, including definitions of QC and its relationship with the complementary process of Quality Assurance (QA), the use of Key Performance Indicators (KPIs) in QC, need for a Corrective and Preventive Action (CAPA) plan and so on. Additionally, the module examines the QA process, focusing on the central role of RBM or risk-based monitoring in present-day QA as well as providing guidelines on Quality Metrics (QMs) for evaluating the trials process. The chapter also reviews ICH-GCP guidelines on subject safety, underlining risk-benefit assessment, stoppage rules (for instance, in case of SAEs) and reporting responsibilities. Finally, it introduces the FDA’s Human Research Protection Program (HRPP) as a platform that provides training and support for personnel involved in clinical trials.

Chapter 23: Technology in Trials

In this chapter, an in-depth tutorial is provided of the systems used in modern clinical trials for Electronic Data Capture (EDC) and database management. Systems such as Interactive Response Technologies (IRTs) including IVRS and IWRS (Interactive Voice and Web Response Systems, respectively) as well as RTSM systems for Randomization and Trial Supply Management are examined.  The unit reviews the benefits of standardized data management and data sharing, approaches to database management and the concept of an Independent Data Monitoring Committee (IDMC). Critical elements of data integrity, such as proper anonymisation and coding, completeness of data, data safety precautions and logging of site visits and other progress reports are highlighted. The unit further examines the essential features of a good Clinical Data Management (CDM) system that complies with FDA CFR Title 21 and HIPAA regulations, such as setting access privileges, tracking changes and updates, data security and locking, flagging and reconciliation of AEs and so forth. Finally, the chapter looks at CTMSs (Clinical Trial Management Systems) in depth, covering the aspects that allow management of day-to-day trials in multi-site studies. 

Chapter 24: Modernized Monitoring (Remote, Risk-based, Centralized)

 This chapter offers a detailed walk-through of modern, remote monitoring of clinical trials, which evolved into a full-fledged system in response to the COVID-19 pandemic. Important concepts discussed include the critical site initiation process, Electronic Source Data Verification (ESDV) and FDA regulatory guidance for remote monitoring of clinical trials. In this module, you will learn how FDA’s ALCOA (Attributable, Legible, Contemporaneous, Original and Accurate) criteria for data quality have been adapted to remote monitoring. Further, the unit discusses how HIPAA compliance in remote monitoring is achieved by using limited data sets (wherein sensitive individual information is concealed through anonymous subject codes) regulated by data use agreements. Finally, the unit examines how risk-based monitoring approaches have allowed centralized monitoring to evolve into a cost-effective and safe method for clinical trial monitoring.

Chapter 25: Pharmacovigilance and Regulatory Affairs

Through this unit, you will gain insight into the process and rationale behind pharmacovigilance (PV) and its central role in the clinical trials process. The chapter reviews the statistics on AEs, distinguishes between Type A and Type B AEs, and profiles seriousness of ADRs or Adverse Drug Reactions as well as the iGuard Drug Risk Rating System. Importantly, the unit covers ADR causality assessment in detail, including both severity and probability assessment. An important element of PV addressed in this module is the Individual Case Safety Report (ICSR), its structure, content and role in trial monitoring. Other concepts discussed include types of PV inspections (routine vs. ‘for cause’), PSURs or Periodic Safety Update Reports and study criteria for instituting DSMBs (Data Safety Management Boards). Finally, the module also reviews the domain of Regulatory Affairs (RA) as a function of PV, outlining roles and responsibilities of RA personnel as well as the importance of RA in streamlining the process of drug development by ensuring compliance throughout manufacturing, clinical trials, marketing and advertising.

Chapter 26: Investigational Product

In this chapter, an in-depth review is provided of the protocol for receiving, storing and dispensing the IP or investigational product. At every stage, guidelines lay down strategies for ensuring verifiability, accountability and safety of both study subjects and staff. Thus, IP handling precautions include the need for logging date of manufacture, temperature throughout transit, as well as batch number and individual unit numbers (such as bottle or tube identifiers) carefully and accurately, as well as recording shipping details and filing shipping receipts. Additionally, the unit addresses the need for IP dispensing precautions, such as limiting dispensation to authorized personnel only, as well as maintaining individual subject IP logs.

Chapter 27: Local and Central Labs

The module profiles the evolution of lab testing in clinical trials, from error-prone localized laboratory testing to centralized testing that allows homogeneity of testing procedures and measurements, thus minimizing errors and improving outcomes. The chapter reviews standards for clinical trial laboratories as per the GLCP (Good Clinical Laboratory Practice) and CLIA norms (Clinical Laboratory Improvement Amendments), as well as providing guidelines for lab audits, including fire safety, protective gear, staff training and so forth.

Chapter 28: Review Questions

The unit contains a self-assessment tool comprising 65 questions that review the content covered in previous chapters, as well as a 15-item quiz. Questions and quiz examine all aspects of trial documentation (SDV, CRF, ICSR), quality control, pharmacovigilance, as well as IP and lab guidelines.

Chapter 29: Regulatory Documents in Clinical Trials

The chapter reviews essential documentation to be created and maintained throughout the course of the clinical trials, including the Trial Master File (TMF), FDA forms 1571, 1572, 3674, 3454/3455 and CFR Title 21 Form 312, besides ethics approval documents such as the IRB-approved protocol, informed consent form, subject education and study advertising materials. You will acquire in-depth familiarity with each of these forms, and learn the importance of maintaining and updating records, for example by incorporating IRB revisions and amendments, periodic renewals of permissions and licenses and copies of submitted reports. In addition, the unit summarizes the need for filing documents outlining study- and site-specific procedures, including SOP (Standard Operating Procedure), MOP (Manual of Procedures), Investigator Brochure (IB), Delegation of Authority Log (DOAL), site staff CVs, SAE notifications, logs of subject screening and enrollment, IP storage (temperature, humidity, etc.) and all relevant study parameters.

Chapter 30: CFR Title 21 Part 11 – Electronic Signatures

This unit gives you an overview of Title 21 of the FDA Code of Federal Regulations (CFR), including Chapter 1 sections on informed consent (Section 50), IRB approval (Section 56) and so on, Series on food (100), pharmaceuticals (200 and 300) and so on, as well as FDA Drug Schedules. The major part of the module focuses on Part 11 which deals with Electronic Records and Electronic Signatures (ERES), laying down the criteria for determining safety and reliability (trustworthiness) of electronic data and signatures.

Chapter 31: New Drug Application

Through this module, you will gain knowledge of the FDA process for evaluating a drug under development, and the role of a CRA in streamlining this process. An important distinction covered here is the difference between an IND (Investigational New Drug) and an NDA (New Drug Application). The chapter discusses in-depth the criteria used in evaluating an IND, including toxicology and pharmacokinetics data, as well as requirements for different drug classes (oncology vs. non-oncology). Additionally, the unit covers FDA requirements for AE reporting, including assessment of seriousness, expectedness and format for expedited reporting of life-threatening SARs, as well as safety reporting requirements for investigators. 

Chapter 32: Trial Master File

The unit provides a detailed breakdown of the organization of a TMF or Trial Master File, listing the various binders that should be included within the TMF, as well as their contents. Thus, the TMF should contain binders pertaining to the study protocol and IRB, investigator qualifications, FDA forms and correspondence, FDFs or Financial Disclosure Forms, communications with the CRO, and other relevant trial aspects. A helpful templatic guide to creating a TMF is also provided in this chapter, as well as a self-assessment quiz of 10 items on important sections of a TMF. 

Chapter 33: Disclosures and Payments for PI, Site, Patients

In this chapter, FDA guidelines regulating financial disclosure are discussed in-depth, covering the definition of ‘conflict of interest’ and the stipulations of Title 21 Section 54 on disclosure requirements. The unit helpfully contrasts FDA requirements with Canadian and UK/EU policies. You will study real life case examples of conflict of interest, as well as lawsuits pertaining to financial disclosure disputes to help gain a better understanding of the potential problems arising from failure to disclose financial interests in clinical trials. Another important dimension covered in the module is the regulation of payments to PIs and other investigators as well as patient payments, which must comply with CMS (Center for Medicare and Medicaid Services) policy on ‘fair market value’ as well as the Federal ‘Anti-Kickback Statute’. The unit contains guidelines on clinical trial budgeting and subject payments. Finally, the chapter reviews IRB guidelines on advertising to recruit human participants for clinical trials, including stipulations against misleading and coercive language, as well as excessive incentives.

Chapter 34: Patient Recruitment, Retention and Compliance

The unit provides an overview of the process of patient (subject) recruitment in clinical trials, from population research to identify motives for participation, to media support for building up public awareness and interest, to community and physician outreach for referrals and enrollment. Additionally, the chapter identifies common barriers to meeting recruitment goals and outlines strategies for maximizing recruitment, such as relaxing overly stringent criteria, offering reasonable incentives such as travel reimbursement and highlighting benefits of participation. Similarly, the unit covers common causes of patient drop-out as well as strategies for minimizing drop-outs, such as improving patient experience (increased attention and listening to patients, flexible scheduling of visits to suit patients’ convenience and so on). Finally, the unit discusses novel strategies to increase patient retention and improve compliance in clinical trials; these techniques harness technology to yield better outcomes, for example, simplifying form completion through digitized forms with auto-fill features, gamifying elements of compliance reporting, and so forth.

Chapter 35: Misconduct and Fraud

This module discusses the various motives for committing scientific fraud and the fallout of fraudulent practices in clinical trials. A scale for classifying errors in clinical trial data is presented, with ‘honest, isolated mistake’ at one end of the spectrum and ‘deliberate data falsification with malicious intent’ at the other. Types of clinical data that may be falsified, methods used in falsification (fabrication, substitution, omission), as well as scenarios in clinical trials where falsification may be occurring are presented. Through this chapter, you will gain familiarity with the signs to watch out for during the actual clinical trials process. 

Chapter 36: Review Questions

The unit contains a self-assessment tool comprising 65 questions that review the content covered in previous chapters, including questions on all aspects of regulatory documents, site documents (TMF and contents), trial budgeting and payments, patient recruitment and scientific fraud.

Chapter 37: Site Visit Templates 

This module contains a set of templates that you can use for documenting the details of site monitoring as a CRA, either in their current form, or in a form adapted to the needs of your own study. The templates included in this unit include:

Site Qualification Visit (SQV) – checklist for preparations, questionnaire for assessing the site prior to the actual visit, assessment form and follow-up letter

Site Initiation Visit (SIV) – agenda for visit, confirmation letter to request PI attendance during SIV, report following SIV

Routine Monitoring Visit (RMV) – confirmation letter to request PI attendance, report following RMV, follow-up letter

Site Close-Out Visit (SCOV)  – confirmation letter to request PI attendance, agenda for SCOV, report following SCOV, follow-up letter

CRA transition letter  – document notifying site PI of appointment of new monitor (yourself as CRA) 

Chapter 38: Interviewing and Career

In this unit, you will find suggestions and recommendations for making a positive impact in interviews for CRA positions, as well as tips and strategies for making rapid progress in a clinical research career.

Chapter 39: Final Examination

This module comprises a comprehensive 51-item, self-paced quiz to assess your competency in the skills and knowledge required for a Clinical Research Associate position. 

https://www.beroeinc.com/category-intelligence/clinical-research-organizations-market/

https://www.linkedin.com/jobs/search?keywords=Clinical%20Research%20Associate&location=United%20States&geoId=103644278&trk=public_jobs_jobs-search-bar_search-submit&position=1&pageNum=0

https://www.centerwatch.com/articles/24791-demand-for-experienced-clinical-trial-professionals-outpacing-supply-acrp-says

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3317309/

https://www.niaid.nih.gov/research/dmid-investigational-product

https://www.fda.gov/patients/clinical-trials-what-patients-need-know/what-are-different-types-clinical-research

Dixon JR. 1999. The international conference on harmonization good clinical practice guideline. Quality Assurance. 6(2): 65-74. DOI: 10.1080/105294199277860

https://www.fda.gov/files/drugs/published/E6%28R2%29-Good-Clinical-Practice--Integrated-Addendum-to-ICH-E6%28R1%29.pdf

https://www.who.int/groups/research-ethics-review-committee/recommended-format-for-a-research-protocol/

https://iaocr.com/finding-first-clinical-research-job/

https://jobs.newscientist.com/en-au/article/a-career-in-clinical-research/

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3326906/

St. Germain DC, Good MJ. 2017. Data management in clinical trials. In: Gallin JI, Ognibene FP, Lee Johnson L, editors. Principles and practice of clinical research. San Diego: Academic Press. p. 531-545. ISBN 978-0-12-849905-4

https://acrpnet.org/wp-content/uploads/dlm_uploads/2017/04/clinical-study-monitoring-competencies.pdf

https://www.clinicalleader.com/doc/starting-a-career-in-clinical-research-things-we-wish-we-knew-0001

https://www.proclinical.com/blogs/2021-9/how-to-get-a-job-as-a-clinical-research-associate-cra

https://acrpnet.org/2018/06/11/5-clinical-research-trends-emerge-at-acrp-2018/

https://www.collegechoice.net/sciences/clinical-research/best-masters-degrees/

https://acrpnet.org/certifications/cra-certification/

https://www.socra.org/certification/program-overview/

Pharmacovigilance: A Complete Guide to Pharmacovigilance and Drug Safety Training

The ultimate guide to clinical research monitoring.

• Program Overview

The SOCRA Certified Clinical Research Professional (CCRP) program is your gateway to excellence in clinical research. Elevate your career with our internationally recognized certification, tailored for professionals dedicated to upholding the highest standards in the field. Join a community committed to ethical practices, continuous learning, and advancing global health. 

The Society of Clinical Research Associates (SOCRA) established the Certification Program for Clinical Research Professionals in order to create an internationally accepted standard of knowledge, education, and experience by which clinical research professionals will be recognized by the clinical research community. Those individuals so recognized may use the "Certified Clinical Research Professional" or "CCRP ®  " designation.

Path to Certification

CCRP certification is awarded upon meeting two criteria: a successful written application and a passing CCRP examination score. The benefits of obtaining certification are numerous. It not only validates knowledge, skills, and abilities but also enhances credibility and peer recognition. Career advancement and increased earning potential become tangible outcomes, reflecting a commitment to standards, compliance, and integrity.

Scope and Standards of Practice 

The standards upon which this certification program is based have been set forth by SOCRA to promote recognition and continuing excellence in the ethical conduct of clinical trials.  It is the goal of SOCRA to encourage members, and assure the competency of certified members, in their knowledge, understanding, and application of the conduct of clinical investigations involving humans in accordance with the ICH Guidelines, the U.S. Code of Federal Regulations, and the ethical principles that guide clinical research. Members are expected to adhere to national, state, local and provincial regulations and to international guidelines published by the International Conference for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and all applicable federal, state and local laws and policies.  

Standards of Practice include an understanding of and application of basic concepts of Good Clinical (Research) Practice, including:

• The Nuremberg Code
• The Belmont Report
• The Declaration of Helsinki
• 21 U.S. Code of Federal Regulations – Parts 11, 50, 56, 312, 812
• 45 U.S. Code of Federal Regulations - Part 46
• ICH Harmonised Guideline for Good Clinical Practice E6(R2), and
• ICH Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (E2A)
• 42 CFR Part 11 (ClinicalTrials.gov) 

Certification Exam

The SOCRA Certification Examination is offered in two formats: paper and pencil (at SOCRA sponsored sites), and computer based (at Prometric testing centers or through Home Proctoring).

SOCRA Sponsored Sites: Paper and Pencil

• Hosted exams offered in various location throughout the US and Canada.
• Visit the paper and pencil exam schedule for dates and locations.
• A complete application must be received by the deadline date as stated on the examination schedule.
• Score reports mailed to you in 4-6 weeks after exam.

Computer Based Testing: Testing Centers and Remote Proctoring 

• Offered at Prometric testing centers throughout the world or through Home Proctoring 
• Click here  for a list of test centers.
• Allow 2-4 weeks for application processing. 
• Once application is approved, schedule exam at a testing center.  Exam sessions are available at least 6 weeks in advance.  
• Score reports received immediately upon completion of exam. 

Candidate Handbook

For more information, please view the  Candidate Handbook.

Certification

• CCRP Certification Quick Facts
• Definition of a Clinical Research Professional
• Certification Program Policies
• Removal of CCRP® Credential
• Verify Certification
• Exam Overview
• Candidate Eligibility
• Application and Fee
• Computer Based Testing Exams
• Paper and Pencil Exams
• Refunds, Rescheduling and Retesting
• SOCRA Sponsored Exam Schedule
• Preparing for the Exam
• Preparation Resources
• Examination Results
• Host an Exam at Your Site
• Apply Online
• Exam Schedule SOCRA Sponsored Sites
• Requirements for Maintaining Certification
• Continuing Education Requirements
• Descriptions of Acceptable CE
• CE Recordkeeping Requirements
• Request for SOCRA CE for Courses / Workshops
• Installment Plan Payment
• Renewal of Certification
• Recertification Audit
• Recertification Learning Module
• Accreditation

Summary of Certification Activities

11,145 CCRPs (as of 12/31/2022)

• 1,391 candidates took CCRP exam
• 73% passed CCRP exam
• 2,649 CCRPs recertified
• 946 candidates took CCRP exam
• 65% passed CCRP exam
• 2,783 CCRPs recertified
• 2,060 candidates took CCRP exam
• 70% passed CCRP exam
• 3,801 CCRPs recertified
• 1,980 candidates took CCRP exam
• 71% passed CCRP exam
• 3,188 CCRPs recertified
• 104 exam sites hosted
• 2,175 candidates took CCRP exam
• 2,491 CCRPs recertified
• 91 exam sites hosted
• 2,141 candidates took CCRP exam
• 2,421CCRPs recertified