clinical research assistant 1

What Does a Research Assistant Do?

Envision yourself at the forefront of medical advancements. If this resonates with you, the role of a clinical research assistant beckons. These professionals are instrumental in facilitating clinical trials, paving the way for groundbreaking medications and devices to receive the Food and Drug Administration (FDA) seal of approval.

As a clinical research assistant, you collaborate with esteemed institutions such as hospitals, clinics, universities, and specialized labs to orchestrate and oversee clinical trials. This role is tailor-made for those with a penchant for data analysis and a passion for research.

Embarking on this journey offers a strategic advantage for those considering paths like nursing, PA, or medical school. So, what is a research assistant’s contribution to the medical realm, and how can it align with your professional aspirations? 

What is a Research Assistant?

At the heart of groundbreaking medical progress lies the pivotal role of the clinical research assistant. These professionals are the backbone supporting researchers as they navigate the intricate landscape of clinical trials. Clinical trials, after all, are the bedrock upon which transformative medical innovations are built, encompassing:

• Medications
• Surgical procedures
• Medical devices

Without clinical trials, every physician would be navigating uncharted waters. They would lack the crucial information needed to determine the effectiveness of a course of treatment for their patients.

Clinical research assistants help to:

• Prepare and clean labs
• Process volunteers
• Care for trial participants
• Organize and record data

They do everything from getting biological samples to taking vital signs. They assist researchers in any way necessary to keep the trial on track and within standards.

Who Can Be a Clinical Research Assistant?

Anyone with an innate curiosity has the potential to do well in this healthcare role. A CRA works closely with medical researchers, healthcare professionals, physicians, and patients. It is a chance to help develop new treatments and drugs that could potentially save lives.

Becoming a clinical research assistant makes sense for someone considering working as a professional in healthcare, too. It is a valuable experience if you are planning to become a:

• Nurse practitioner
• Medical researcher

Working in clinical trials will look excellent on a resume and graduate school application. It is also a chance to get a valuable job in healthcare without spending a lot of time in school or going into debt.

How to Become a Clinical Research Assistant

At Advanced eClinical Training (ACT), we’ve streamlined the journey for aspiring clinical research assistants. Our online medical certifications , designed with flexibility and affordability in mind, empower you to delve deep into the realm of clinical research at your own pace. In a mere four weeks, ACT’s Advanced Clinical Research Assistant program can equip you with:

• Comprehensive insights into the nuances of conducting clinical trials.
• Mastery of clinical research methodologies, terminologies, and protocols.
• A coveted certification as an Advanced Clinical Research Assistant (ACRA).

Upon course completion, you will have a working knowledge of:

• Different types of clinical trials and the study phases involved in each
• Regulations, protocols, and guidelines for good clinical practice in trials
• Protection of the clinical trial participants
• Research design
• Data Collection
• Data management

Our curriculum is meticulously structured into seven modules, enriched with interactive tools, simulations, and real-world scenarios. These modules are designed to challenge and engage, ensuring you receive instant feedback on your grasp of the material.

ACT’s courses are accessible around the clock and compatible with any device, offering you the luxury of learning at your convenience.

Graduating from our program not only qualifies you to serve as a clinical research assistant in leading medical and academic labs but also arms you with a professional accolade that can bolster your graduate school applications.

At Advanced eClinical Training, our forte lies in curating medical certifications tailored for pre-health students. Our suite of courses, including the esteemed Good Clinical Practice (GCP) certificate, is crafted to pave your way in the healthcare sector seamlessly.

Why wait? Enroll today and embark on your journey with ACT’s Advanced Clinical Research Assistants course or explore our diverse range of online medical certifications to kickstart your healthcare career on the right note.

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Baylor Scott & White Health Care System

Clinical research assistant.

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The Clinical Research Assistant 1 assists the research team in the implementation and conduct of clinical trials per federal, state and institutional guidelines by performing delegated tasks during all phases of trials from pre-study implementation through study closure.

ESSENTIAL FUNCTIONS OF THE ROLE

• Assists with the implementation and conduct of clinical research projects as delegated to assure successful achievement of quality, safety, regulatory and financial outcomes including maintaining regulatory binders, recruiting and retaining study subjects, researching billing compliance, performing procedures and collecting data, query resolution.
• Performs specific technical tasks and procedures which may include performing phlebotomies, recording test subject’s vital signs, height and weight, collecting and distributing subject diaries and questionnaires and other study specific procedures or tests as assigned. Records data.
• Assists with approved research subject recruitment, retention and communication including conducting telephone screens, participating in research marketing activities such as health fairs, building and maintaining department databases of potential subjects, scheduling study subject appointments, making and receiving subject telephone calls and relaying appropriate information.
• Maintains inventory of study-specific and clinical supplies. Works to assure protocol compliance and efficient workflow including organizing clinical work areas, counting and ordering lab kits, shipping materials and checking and replacing expired items.
• Prepares Institutional Review Board materials and communications.

Clinical Researcher

Navigating a Career as a Clinical Research Professional: Where to Begin?

Clinical Researcher June 9, 2020

Clinical Researcher—June 2020 (Volume 34, Issue 6)

PEER REVIEWED

Bridget Kesling, MACPR; Carolynn Jones, DNP, MSPH, RN, FAAN; Jessica Fritter, MACPR; Marjorie V. Neidecker, PhD, MEng, RN, CCRP

Those seeking an initial career in clinical research often ask how they can “get a start” in the field. Some clinical research professionals may not have heard about clinical research careers until they landed that first job. Individuals sometimes report that they have entered the field “accidentally” and were not previously prepared. Those trying to enter the clinical research field lament that it is hard to “get your foot in the door,” even for entry-level jobs and even if you have clinical research education. An understanding of how individuals enter the field can be beneficial to newcomers who are targeting clinical research as a future career path, including those novices who are in an academic program for clinical research professionals.

We designed a survey to solicit information from students and alumni of an online academic clinical research graduate program offered by a large public university. The purpose of the survey was to gain information about how individuals have entered the field of clinical research; to identify facilitators and barriers of entering the field, including advice from seasoned practitioners; and to share the collected data with individuals who wanted to better understand employment prospects in clinical research.

Core competencies established and adopted for clinical research professionals in recent years have informed their training and education curricula and serve as a basis for evaluating and progressing in the major roles associated with the clinical research enterprise.{1,2} Further, entire academic programs have emerged to provide degree options for clinical research,{3,4} and academic research sites are focusing on standardized job descriptions.

For instance, Duke University re-structured its multiple clinical research job descriptions to streamline job titles and progression pathways using a competency-based, tiered approach. This led to advancement pathways and impacted institutional turnover rates in relevant research-related positions.{5,6} Other large clinical research sites or contract research organizations (CROs) have structured their onboarding and training according to clinical research core competencies. Indeed, major professional organizations and U.S. National Institutes of Health initiatives have adopted the Joint Task Force for Clinical Trial Competency as the gold standard approach to organizing training and certification.{7,8}

Recent research has revealed that academic medical centers, which employ a large number of clinical research professionals, are suffering from high staff turnover rates in this arena, with issues such as uncertainty of the job, dissatisfaction with training, and unclear professional development and role progression pathways being reported as culprits in this turnover.{9} Further, CROs report a significant shortage of clinical research associate (CRA) personnel.{10} Therefore, addressing factors that would help novices gain initial jobs would address an important workforce gap.

This mixed-methods survey study was initiated by a student of a clinical research graduate program at a large Midwest university who wanted to know how to find her first job in clinical research. Current students and alumni of the graduate program were invited to participate in an internet-based survey in the fall semester of 2018 via e-mails sent through the program listservs of current and graduated students from the program’s lead faculty. After the initial e-mail, two reminders were sent to prospective participants.

The survey specifically targeted students or alumni who had worked in clinical research. We purposefully avoided those students with no previous clinical research work experience, since they would not be able to discuss their pathway into the field. We collected basic demographic information, student’s enrollment status, information about their first clinical research position (including how it was attained), and narrative information to describe their professional progression in clinical research. Additional information was solicited about professional organization membership and certification, and about the impact of graduate education on the acquisition of clinical research jobs and/or role progression.

The survey was designed so that all data gathered (from both objective responses and open-ended responses) were anonymous. The survey was designed using the internet survey instrument Research Electronic Data Capture (REDCap), which is a secure, web-based application designed to support data capture for research studies. REDCap provides an intuitive interface for validated data entry; audit trails for tracking data manipulation and export procedures; automated export procedures for seamless data downloads to common statistical packages; and procedures for importing data from external sources.{11}

Data were exported to Excel files and summary data were used to describe results. Three questions solicited open-ended responses about how individuals learned about clinical research career options, how they obtained their first job, and their advice to novices seeking their first job in clinical research. Qualitative methods were used to identify themes from text responses. The project was submitted to the university’s institutional review board and was classified as exempt from requiring board oversight.

A total of 215 survey invitations were sent out to 90 current students and 125 graduates. Five surveys were returned as undeliverable. A total of 48 surveys (22.9%) were completed. Because the survey was designed to collect information from those who were working or have worked in clinical research, those individuals (n=5) who reported (in the first question) that they had never worked in clinical research were eliminated. After those adjustments, the total number completed surveys was 43 (a 20.5% completion rate).

The median age of the participants was 27 (range 22 to 59). The majority of respondents (89%) reported being currently employed as clinical research professionals and 80% were working in clinical research at the time of graduate program entry. The remaining respondents had worked in clinical research in the past. Collectively, participants’ clinical research experience ranged from less than one to 27 years.

Research assistant (20.9%) and clinical research coordinator (16.3%) were the most common first clinical research roles reported. However, a wide range of job titles were also reported. When comparing entry-level job titles of participants to their current job title, 28 (74%) respondents reported a higher level job title currently, compared to 10 (26%) who still had the same job title.

Twenty-four (65%) respondents were currently working at an academic medical center, with the remaining working with community medical centers or private practices (n=3); site management organizations or CROs (n=2); pharmaceutical or device companies (n=4); or the federal government (n=1).

Three respondents (8%) indicated that their employer used individualized development plans to aid in planning for professional advancement. We also asked if their current employer provided opportunities for professional growth and advancement. Among academic medical center respondents, 16 (67%) indicated in the affirmative. Respondents also affirmed growth opportunities in other employment settings, with the exception of one respondent working in government and one respondent working in a community medical center.

Twenty-five respondents indicated membership to a professional association, and of those, 60% reported being certified by either the Association of Clinical Research Professionals (ACRP) or the Society of Clinical Research Associates (SoCRA).

Open-Ended Responses

We asked three open-ended questions to gain personal perspectives of respondents about how they chose clinical research as a career, how they entered the field, and their advice for novices entering the profession. Participants typed narrative responses.

“Why did you decide to pursue a career in clinical research?”

This question was asked to find out how individuals made the decision to initially consider clinical research as a career. Only one person in the survey had exposure to clinical research as a career option in high school, and three learned about such career options as college undergraduates. One participant worked in clinical research as a transition to medical school, two as a transition to a doctoral degree program, and two with the desire to move from a bench (basic science) career to a clinical research career.

After college, individuals either happened across clinical research as a career “by accident” or through people they met. Some participants expressed that they found clinical research careers interesting (n=6) and provided an opportunity to contribute to patients or improvements in healthcare (n=7).

“How did you find out about your first job in clinical research?”

Qualitative responses were solicited to obtain information on how participants found their first jobs in clinical research. The major themes that were revealed are sorted in Figure 1.

Figure 1: How First Jobs in Clinical Research Were Found

Some reported finding their initial job through an institution’s job posting.

“I worked in the hospital in the clinical lab. I heard of the opening after I earned my bachelor’s and applied.”

Others reported finding about their clinical research position through the internet. Several did not know about clinical research roles before exploring a job posting.

“In reviewing jobs online, I noticed my BS degree fit the criteria to apply for a job in clinical research. I knew nothing about the field.”

“My friend recommended I look into jobs with a CRO because I wanted to transition out of a production laboratory.”

“I responded to an ad. I didn’t really know that research could be a profession though. I didn’t know anything about the field, principles, or daily activities.”

Some of the respondents reported moving into a permanent position after a role as an intern.

“My first clinical job came from an internship I did in my undergrad in basic sleep research. I thought I wanted to get into patient therapies, so I was able to transfer to addiction clinical trials from a basic science lab. And the clinical data management I did as an undergrad turned into a job after a few months.”

“I obtained a job directly from my graduate school practicum.”

“My research assistant internship [as an] undergrad provided some patient enrollment and consenting experience and led to a CRO position.”

Networking and referrals were other themes that respondents indicated had a direct impact on them finding initial employment in clinical research.

“I received a job opportunity (notice of an opening) through my e-mail from the graduate program.”

“I was a medical secretary for a physician who did research and he needed a full-time coordinator for a new study.”

“I was recommended by my manager at the time.”

“A friend had a similar position at the time. I was interested in learning more about the clinical research coordinator position.”

“What advice do you have for students and new graduates trying to enter their first role in clinical research?”

We found respondents (n=30) sorted into four distinct categories: 1) a general attitude/approach to job searching, 2) acquisition of knowledge/experience, 3) actions taken to get a position, and 4) personal attributes as a clinical research professional in their first job.

Respondents stressed the importance of flexibility and persistence (general attitude/approach) when seeking jobs. Moreover, 16 respondents stressed the importance of learning as much as they could about clinical research and gaining as much experience as they could in their jobs, encouraging them to ask a lot of questions. They also stressed a broader understanding of the clinical research enterprise, the impact that clinical research professional roles have on study participants and future patients, and the global nature of the enterprise.

“Apply for all research positions that sound interesting to you. Even if you don’t meet all the requirements, still apply.”

“Be persistent and flexible. Be willing to learn new skills and take on new responsibilities. This will help develop your own niche within a group/organization while creating opportunities for advancement.”

“Be flexible with salary requirements earlier in your career and push yourself to learn more [about the industry’s] standards [on] a global scale.”

“Be ever ready to adapt and change along with your projects, science, and policy. Never forget the journey the patients are on and that we are here to advance and support it.”

“Learning the big picture, how everything intertwines and works together, will really help you progress in the field.”

In addition to learning as much as one can about roles, skills, and the enterprise as a whole, advice was given to shadow or intern whenever possible—formally or through networking—and to be willing to start with a smaller company or with a lower position. The respondents stressed that novices entering the field will advance in their careers as they continue to gain knowledge and experience, and as they broaden their network of colleagues.

“Take the best opportunity available to you and work your way up, regardless [if it is] at clinical trial site or in industry.”

“Getting as much experience as possible is important; and learning about different career paths is important (i.e., not everyone wants or needs to be a coordinator, not everyone goes to graduate school to get a PhD, etc.).”

“(A graduate) program is beneficial as it provides an opportunity to learn the basics that would otherwise accompany a few years of entry-level work experience.”

“Never let an opportunity pass you up. Reach out directly to decision-makers via e-mail or telephone—don’t just rely on a job application website. Be willing to start at the bottom. Absolutely, and I cannot stress this enough, [you should] get experience at the site level, even if it’s just an internship or [as a] volunteer. I honestly feel that you need the site perspective to have success at the CRO or pharma level.”

Several personal behaviors were also stressed by respondents, such as knowing how to set boundaries, understanding how to demonstrate what they know, and ability to advocate for their progression. Themes such as doing a good job, communicating well, being a good team player, and sharing your passion also emerged.

“Be a team player, ask questions, and have a good attitude.”

“Be eager to share your passion and drive. Although you may lack clinical research experience, your knowledge and ambition can impress potential employers.”

“[A] HUGE thing is learning to sell yourself. Many people I work with at my current CRO have such excellent experience, and they are in low-level positions because they didn’t know how to negotiate/advocate for themselves as an employee.”

This mixed-methods study used purposeful sampling of students in an academic clinical research program to gain an understanding of how novices to the field find their initial jobs in the clinical research enterprise; how to transition to a clinical research career; and how to find opportunities for career advancement. There are multiple clinical research careers and employers (see Figure 2) available to individuals working in the clinical research enterprise.

Figure 2: Employers and Sample Careers

Despite the need for employees in the broad field of clinical research, finding a pathway to enter the field can be difficult for novices. The lack of knowledge about clinical research as a career option at the high school and college level points to an opportunity for broader inclusion of these careers in high school and undergraduate curricula, or as an option for guidance counselors to be aware of and share with students.

Because most clinical research jobs appear to require previous experience in order to gain entry, novices are often put into a “Catch-22” situation. However, once hired, upward mobility does exist, and was demonstrated in this survey. Mobility in clinical research careers (moving up and general turnover) may occur for a variety of reasons—usually to achieve a higher salary, to benefit from an improved work environment, or to thwart a perceived lack of progression opportunity.{9}

During COVID-19, there may be hiring freezes or furloughs of clinical research staff, but those personnel issues are predicted to be temporary. Burnout has also been reported as an issue among study coordinators, due to research study complexity and workload issues.{12} Moreover, the lack of individualized development planning revealed by our sample may indicate a unique workforce development need across roles of clinical research professionals.

This survey study is limited in that it is a small sample taken specifically from a narrow cohort of individuals who had obtained or were seeking a graduate degree in clinical research at a single institution. The study only surveyed those currently working in or who have a work history in clinical research. Moreover, the majority of respondents were employed at an academic medical center, which may not fully reflect the general population of clinical research professionals.

It was heartening to see the positive advancement in job titles for those individuals who had been employed in clinical research at program entry, compared to when they responded to the survey. However, the sample was too small to draw reliable correlations about job seeking or progression.

Although finding one’s first job in clinical research can be a lengthy and discouraging process, it is important to know that the opportunities are endless. Search in employment sites such as Indeed.com, but also search within job postings for targeted companies or research sites such as biopharmguy.com (see Table 1). Created a LinkedIn account and join groups and make connections. Participants in this study offered sound advice and tips for success in landing a job (see Figure 3).

Table 1: Sample Details from an Indeed.Com Job Search

Note: WCG = WIRB Copernicus Group

Figure 3: Twelve Tips for Finding Your First Job

• Seek out internships and volunteer opportunities
• Network, network, network
• Be flexible and persistent
• Learn as much as possible about clinical research
• Consider a degree in clinical research
• Ask a lot of questions of professionals working in the field
• Apply for all research positions that interest you, even if you think you are not qualified
• Be willing to learn new skills and take on new responsibilities
• Take the best opportunity available to you and work your way up
• Learn to sell yourself
• Sharpen communication (written and oral) and other soft skills
• Create an ePortfolio or LinkedIn account

Being willing to start at the ground level and working upwards was described as a positive approach because moving up does happen, and sometimes quickly. Also, learning soft skills in communication and networking were other suggested strategies. Gaining education in clinical research is one way to begin to acquire knowledge and applied skills and opportunities to network with experienced classmates who are currently working in the field.

Most individuals entering an academic program have found success in obtaining an initial job in clinical research, often before graduation. In fact, the student initiating the survey found a position in a CRO before graduation.

• Sonstein S, Seltzer J, Li R, Jones C, Silva H, Daemen E. 2014. Moving from compliance to competency: a harmonized core competency framework for the clinical research professional. Clinical Researcher 28(3):17–23. doi:10.14524/CR-14-00002R1.1. https://acrpnet.org/crjune2014/
• Sonstein S, Brouwer RN, Gluck W, et al. 2018. Leveling the joint task force core competencies for clinical research professionals. Therap Innov Reg Sci .
• Jones CT, Benner J, Jelinek K, et al. 2016. Academic preparation in clinical research: experience from the field. Clinical Researcher 30(6):32–7. doi:10.14524/CR-16-0020. https://acrpnet.org/2016/12/01/academic-preparation-in-clinical-research-experience-from-the-field/
• Jones CT, Gladson B, Butler J. 2015. Academic programs that produce clinical research professionals. DIA Global Forum 7:16–9.
• Brouwer RN, Deeter C, Hannah D, et al. 2017. Using competencies to transform clinical research job classifications. J Res Admin 48:11–25.
• Stroo M, Ashfaw K, Deeter C, et al. 2020. Impact of implementing a competency-based job framework for clinical research professionals on employee turnover. J Clin Transl Sci.
• Calvin-Naylor N, Jones C, Wartak M, et al. 2017. Education and training of clinical and translational study investigators and research coordinators: a competency-based approach. J Clin Transl Sci 1:16–25. doi:10.1017/cts.2016.2
• Development, Implementation and Assessment of Novel Training in Domain-based Competencies (DIAMOND). Center for Leading Innovation and Collaboration (CLIC). 2019. https://clic-ctsa.org/diamond
• Clinical Trials Talent Survey Report. 2018. http://www.appliedclinicaltrialsonline.com/node/351341/done?sid=15167
• Causey M. 2020. CRO workforce turnover hits new high. ACRP Blog . https://acrpnet.org/2020/01/08/cro-workforce-turnover-hits-new-high/
• Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. 2009. Research electronic data capture (REDCap): a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform 42:377–81.
• Gwede CK, Johnson DJ, Roberts C, Cantor AB. 2005. Burnout in clinical research coordinators in the United States. Oncol Nursing Forum 32:1123–30.

A portion of this work was supported by the OSU CCTS, CTSA Grant #UL01TT002733.

Bridget Kesling, MACPR, ( [email protected] ) is a Project Management Analyst with IQVIA in Durham, N.C.

Carolynn Jones, DNP, MSPH, RN, FAAN, ( [email protected] ) is an Associate Professor of Clinical Nursing at The Ohio State University College of Nursing, Co-Director of Workforce Development for the university’s Center for Clinical and Translational Science, and Director of the university’s Master of Clinical Research program.

Jessica Fritter, MACPR, ( [email protected] ) is a Clinical Research Administration Manager at Nationwide Children’s Hospital and an Instructor for the Master of Clinical Research program at The Ohio State University.

Marjorie V. Neidecker, PhD, MEng, RN, CCRP,  ( [email protected] ) is an Assistant Professor of Clinical Nursing at The Ohio State University Colleges of Nursing and Pharmacy.

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Clinical Research Assistant Salary in the United States

Clinical Research Assistant Salary

How much does a Clinical Research Assistant make in the United States? The average Clinical Research Assistant salary in the United States is $70,000 as of April 24, 2024, but the range typically falls between $60,200 and $80,900 . Salary ranges can vary widely depending on many important factors, including education , certifications, additional skills, the number of years you have spent in your profession. With more online, real-time compensation data than any other website, Salary.com helps you determine your exact pay target.

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Travel Clinical Research Coordinator - $2,200 per week

Alliance Services, Inc. - Green Bay, WI

Travel Clinical Research Coordinator - $1,020 per week

TalentBurst, Inc - New York, NY

Clinical Research Coordinator

CARLE - Peoria, IL

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Job Description

The Clinical Research Assistant selects and observes subjects and assists with data analysis and reporting. Organizes research information for clinical projects. Being a Clinical Research Assistant requires a high school diploma or its equivalent. Oversees experiment scheduling and collection of data. In addition, Clinical Research Assistant typically reports to a supervisor or manager. Being a Clinical Research Assistant gains or has attained full proficiency in a specific area of discipline. Works under moderate supervision. Working as a Clinical Research Assistant typically requires 1-3 years of related experience. (Copyright 2024 Salary.com)

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Clinical Research Assistant

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COLUMBIA UNIVERSITY IN THE CITY OF NEW YORK

Clinical Research Coordinator

• Obstetrics and Gynecology
• Columbia University Medical Center
• Opening on: May 1 2024
• Job Type: Officer of Administration
• Bargaining Unit:
• Regular/Temporary: Regular
• End Date if Temporary:
• Hours Per Week: 35
• Standard Work Schedule:
• Salary Range: $62,400 - $63,000

Position Summary

The primary role of this position is to support clinical research involving Maternal Fetal Medicine Research. The employee will interact with pregnant women, their families and clinical staff as it relates to clinical research protocols and clinical trials, industry funded and grant funded, being implemented in the inpatient and outpatient setting. The inpatient setting includes labor and delivery, ante-partum and post-partum.  The outpatient setting includes ACN clinics, Columbia doctor’s private offices, and ultrasound units.

Responsibilities

• Complete of GCP, HIPAA and applicable regulatory training.

Complete certification requirements for assigned protocols.

Screen designated schedules or patient lists for eligible subjects.

Contact, approach and verify eligibility subjects.

Screen, enroll and consent eligible subjects.

Complete research study visits as delineated in assigned protocol and manual of operations set forth by sponsor and supervisor.

Complete Telephone follow-up and telephone reminder calls for study participants, during these phone calls the person will need to administer study questionnaire as assigned.

Coordinate the collection of all research data points as assigned, whether through research visits, chart abstraction or telephone.

Schedule of research visits; enter research data into a centralized database program and other study specific electronic databases.

Collect through venipuncture, process, track, transport and ship biological specimens (including birth specimens) as assigned and by steps delineated in the protocol or manual of operations.

Complete study documents and files some examples might include case report forms, worksheets and medical record notes.

Maintain confidentiality of documents and files such as HIPPA.

Inform relevant clinical staff regarding subject protocol participation.

Assist in other research related activities and projects as needed.

Collaborate regularly with the investigators and other research staff.

Consult with medical records of outlying clinics and hospitals to obtain pertinent data and patient information.

Interface with various hospital departments such as medical records, radiology, nursing, information technology services, and others as needed.

Attend and participate in Investigator, site initiation and monitoring meetings as assigned.

Participate in on-call activities to cover research activity off- hours as needed.

Perform other related duties and responsibilities as assigned/requested.

Minimum Qualifications

• Requires a bachelor’s degree or equivalent in education and experience.
• Phlebotomy Certified (or other forms of certification in lieu of phlebotomy such as certified medical assistant, nurse degree (LPN, RN) - current or obtained within 3 months.
• Complete proficiency in written and spoken English.
• Incumbent must be self-directed and able to make independent decision within the parameters of all federal, state, institutional and departmental guidelines.

Preferred Qualifications

• Experience in a patient care setting and clinical research experience.
• Excellent interpersonal, written/oral communication, and organizational skills.
• Proficiency in Microsoft Office.
• Master’s or another advanced degree may substitute in part for experience.

The Department of Obstetrics and Gynecology is dedicated to the goal of building a multicultural faculty and staff committed to teaching, working and serving in a diverse community, and strongly encourages applications from candidates of traditionally underrepresented backgrounds. We are continuously seeking to recruit individuals who will enhance the diversity of our workplace and the effectiveness of our organization.

Equal Opportunity Employer / Disability / Veteran

Columbia University is committed to the hiring of qualified local residents.

Commitment to Diversity 

Columbia university is dedicated to increasing diversity in its workforce, its student body, and its educational programs. achieving continued academic excellence and creating a vibrant university community require nothing less. in fulfilling its mission to advance diversity at the university, columbia seeks to hire, retain, and promote exceptionally talented individuals from diverse backgrounds.  , share this job.

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Clinical Research Coordinator/Regulatory Assistant, Cancer Care

Research tech.

• 1 Boston Medical Center Place, Boston, Massachusetts

Position: Clinical Research Coordinator/Regulatory Assistant      

Location: Boston, MA

Schedule: 40 hours per week

At Boston Medical Center (BMC), our diverse staff works together for one goal — to provide exceptional and equitable care to improve the health of the people of Boston. Our bold vision to transform health care is powered by our respect for our patients and our commitment to ensure everyone who comes through our doors has a positive experience.

You’ll find a supportive work environment at BMC, with rich opportunities throughout your career for training, development, and growth and where you’ll have the tools you need to take charge of your own practice environment.  

POSITION SUMMARY:

The CRC/Regulatory Assistant is responsible to ensure the maintenance of regulatory documentation for the portfolio of studies within the program. This person prepares and submits IRB continuing review reports, amendments, revisions, deviation reports, protocol exceptions, CAPAs, new information and unanticipated events and safety reports to local and central IRBs for Industry sponsored and NCI- sponsored clinical trials.

JOB RESPONSIBILITIES:

• Meeting Scheduling: pre-study visits, site selection and site initiation visits, monitoring visits and monthly sponsor updates
• Coordinates with representatives of pharmaceutical companies and/or CROs as required for site feasibility visits, site initiation visits, all monitoring/audit visits, and study close out visits for all studies. 
• Carries out study preparation for investigator meetings, site training, tracking of these activities, and resolves queries raised by other study teams and CROs.
• Assists the Sr. Regulatory Manager to perform Quality Control checks in preparation for audits or site monitors for industry-sponsored protocols. Ensures that the CH-CRP office is “audit-ready” at all times, with regard to regulatory documentation

ADMINISTRATIVE

• Submits and maintains timely documentation for investigator research licenses along with submission of annual NCI Investigator renewal packets (RCR) to the FDA for each investigator.
• Maintain current certifications in Good Clinical Practice, the Protection of Human Subjects and HIPAA, CVs, IND research licenses
• Maintain basic regulatory documents across all studies within the Cancer & Hematology Clinical Research Program.
• Maintains regulatory binders with the above documents as well as IRB approvals and study-related correspondence for each protocol from pre-activation through close-out, making sure to update each document as information changes or the document expires.

(The above statements in this job description are intended to depict the general nature and level of work assigned to the employee(s) in this job.  The above is not intended to represent an exhaustive list of accountable duties and responsibilities required).

JOB REQUIREMENTS

• Baccalaureate Degree Required AND 0-2 years experience

KNOWLEDGE AND SKILLS:

• Excellent organization and communications skills required.
• Strong interpersonal skills; ability to effectively interact with all levels of staff and externals contacts.
• Must be detail oriented and have the ability to follow-through.
• Ability to effectively manage time and prioritize workload. Must practice discretion and adhere to hospital confidentiality guidelines at all times.
• Must have computer skills including the use of Microsoft Office Suite

JOB BENEFITS:

• Competitive pay
• Tuition reimbursement and tuition remission programs
• Highly subsidized medical, dental, and vision insurance options
• Career Advancement/Professional Development: Access a wealth of ongoing training and development opportunities that will not only enhance your skills but also expand your knowledge base especially for individuals pursuing careers in medicine or biomedical research.
• Pioneering Research: Engage in groundbreaking research projects that are driving the forefront of biomedical science.

ABOUT THE DEPARTMENT:

As the primary teaching hospital for Boston University Chobanian & Avedisian School of Medicine and BU schools of public health and dentistry, intellectual rigor shapes our inquiries. Our research is led by a belief that skin color, zip code, and financial circumstances shouldn’t dictate health.

Boston Medical Center is an Equal Opportunity/Affirmative Action Employer. If you need accommodation for any part of the application process because of a medical condition or disability, please send an e-mail to  [email protected]  or call 617-638-8582 to let us know the nature of your request.

Equal Opportunity Employer/Disabled/Veterans

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EEO & Accommodation Statement Boston Medical Center is an equal employment/affirmative action employer. We ensure equal employment opportunities for all, without regard to race, color, religion, sex, national origin, age, disability, veteran status, sexual orientation, gender identity and/or expression or any other non-job-related characteristic. If you need accommodation for any part of the application process because of a medical condition or disability, please send an e-mail to [email protected] or call 617-638-8582 to let us know the nature of your request

E-Verify Program Boston Medical Center participates in the Electronic Employment Verification Program. As an E-Verify employer, prospective employees of BMC must complete a background check and receive medical clearance before beginning their employment at the hospital.

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Phase 3 trial of coronavir (favipiravir) in patients with mild to moderate COVID-19

Affiliations.

• 1 Clinical Research Department, The Federal Budget Institute of Science "Central Research Institute for Epidemiology" of The Federal Service on Customers' Rights Protection and Human Well-being Surveillance Moscow, Russia.
• 2 Medical Center "Eco-safety" Saint-Petersburg, Russia.
• 3 Medical Center "Group of Companies "MEDSI" JSC Moscow, Russia.
• 4 Clinical Pharmacology Department, "Clinical Hospital of Zhukovsky" Zhukovsky, Russia.
• 5 Medical Center "Neuroprofi" LLC Korolev, Russia.
• 6 L.A. Vorokhobov City Clinical Hospital No. 67 of The Moscow City Healthcare Department Moscow, Russia.
• 7 City Clinical Hospital No. 52 of The Moscow City Healthcare Department Moscow, Russia.
• 8 Infectious Clinical Hospital No. 1 of The Moscow City Healthcare Department Moscow, Russia.
• 9 Voronezh Regional Clinical Hospital No. 1 Voronezh, Russia.
• 10 City Hospital No. 40 of The Kurortny District Sestroretsk, Russia.
• 11 N.I. Pirogov National Medical and Surgical Center of The Ministry of Health of The Russian Federation Moscow, Russia.
• 12 N.N. Burdenko National Medical Research Centr of Neurosurgery of The Ministry of Health of The Russian Federation Moscow, Russia.
• 13 R-Pharm Group of Companies Moscow, Russia.
• PMID: 34956474
• PMCID: PMC8661194

Favipiravir has demonstrated efficacy against the SARS-CoV-2 virus in several preliminary studies. This study aimed to evaluate the efficacy and safety of favipiravir for treatment of mild to moderate COVID-19 in outpatients and hospitalized patients. We conducted an open-label, randomized, active-controlled trial of a generic form of favipiravir in patients with COVID-19 confirmed by PCR-test. Eligible patients (18-60 years) after stratification were randomly assigned (in a 2:1 ratio) to receive either favipiravir (1800 mg BID on day 1, followed by 800 mg BID for up to 9 days), or standard of care (SOC) treatment (umifenovir + intranasal interferon alpha-2b, or hydroxychloroquine) for up to 10 days. The co-primary outcomes were the time to clinical improvement and the time to viral clearance. Among 190 patients assessed for eligibility 168 were randomized to favipiravir (n=112) or to SOC (n=56) group. The median time to clinical improvement was 6.0 days (IQR 4.0; 9.3) in the favipiravir group and 10.0 (IQR 5.0; 21.0) days in the SOC group; the median difference was 4 days (HR 1.63; 95% CI 1.14-2.34; P=0.007). The statistically significant difference in the median time to viral clearance was observed only for hospitalized patients: 3.0 (IQR 3.0; 3.0) days in the favipiravir group vs. 5.0 (IQR 4.5; 5.5) days in the SOC group (HR 2.11; 95% CI 1.04-4.31; P=0.038). The rate of viral elimination on Day 5 in the favipiravir group was significantly higher than in SOC group: 81.2% vs. 67.9% (RR 1.22; 05% CI 1.00-1.48; P=0.022). The rate of clinical improvement on Day 7 in the favipiravir group was 1.5-fold higher than in SOC group: 52.7% vs. 35.8% (RR 1.50; 95% CI 1.02-2.22; P=0.020). Favipiravir was well-tolerated and the most common adverse reactions were asymptomatic hyperuricemia, transient elevation of ALT & AST, and mild gastrointestinal disorders. Favipiravir was superior to the SOC in shortening the time to clinical improvement in patients with mild to moderate COVID-19.

Keywords: COVID-19; SARS-CoV-2; coronavirus; favipiravir.

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