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Aspiring CRAs

So, you’d like to become a Clinical Research Associate (CRA)? Read on for some useful tips from NZACRes…

What does a CRA do?

A CRA monitors the running of clinical trials. This is achieved by conducting onsite monitoring visits, remote site monitoring calls and liaising between the sites and the project team. A typical job description looks like this:

• Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.
• Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.
• Gains an in-depth understanding of the study protocol ​and related procedures.
• Coordinates & manages various tasks in collaboration with other sponsor roles to achieve site activation.
• Participates & provides inputs on site selection and validation activities.

What qualifications are required to be a CRA?

• A degree in life sciences or other health-related discipline
• A masters or PhD may be advantageous. A relevant PhD may also be helpful in securing promotions to more senior positions in this career path.

Some useful terminology:

• Site: the clinical site where the patient takes part in the clinical trial.
• Sponsor: the pharmaceutical or medical device company that is paying to conduct the clinical trial.
• CRO: Clinical Research Organization/Contract Research Organization: a company hired by the Sponsor to oversee the conduct of the clinical trial. Note: some Sponsors may not use CROs and instead have their own dedicated CRAs.
• CRA I or in-house CRA: This is an entry-level position and usually works under the supervision of more senior CRAs.
• CRA II : an independent CRA. Can perform monitoring visits without supervision.
• SCRA: Senior CRA – an experienced CRA. May also take on lead CRA responsibilities and oversee a team of CRAs.
• Oncology CRAs: oncology trials have additional clinical monitoring challenges. Some CROs/Sponsors may seek CRAs with oncology experience.
• SSU: Study Start-Up – work alongside CRAs. SSU specialists collect the Essential Documents (ICH-GCP Section 8) required prior to the start of the study. Once a site has been selected and prior to the Site Initiation Visit, the SSU team will handover the site to the CRA for initiation. Depending on the CRO, SSU specialists may retain HDEC and regulatory responsibilities during the project life-cycle.
• CTA: Clinical Trials Assistant – assist CRAs with various aspects of the project including TMF filing, ISF creation, updating study documents.
• CMA: Central Monitoring Associate – similar to a CRA but works remotely and does not visit sites in person. CMAs analyse the data collected and identify risks and trends for the CRAs to follow up with the sites.

What should you do next?

• Join NZACRes! Members enjoy access to the video library of relevant clinical research topics to NZ. We recommend that you watch the ‘Careers’ webinar, available within our video library.  NZACRes membership will help to show that you’re interested in keeping up to date and connecting with local industry experts.
• Complete a FREE online GCP course and proudly display this on your CV and LinkedIn page. Members have access to a list of free courses under the Members Resources page ‘Online Resources’ .
• Make sure your LinkedIn profile is up to date. See our LinkedIn tips article here:  https://www.nzacres.org.nz/nz_jobs/linkedin-tips/
• Make sure your CV is up-to-date and professionally presented. We recommend you use a research template, such as the Transcelerate CV template. 
• Search LinkedIn and Seek for clinical research jobs. If you can’t find a CRA I position, try talking to recruiters hiring for CRA II positions. If all the positions require “industry experience”, meaning experience working on clinical trials conducted according to ICH-GCP, you may like to try looking for other positions e.g. clinical research coordinator, clinical research assistant, clinical trial assistant, research recruiter, data entry, research nurse (if you have a nursing background), clinical trials pharmacist (if you’re a pharmacist), lab assistant. Please note that you’re trying to get experience on industry Sponsored clinical trials – testing new medicines or medical devices – conducted according to ICH-GCP (or ISO14155 for medical devices). The clinical studies conducted in academia may not meet these criteria and, while valuable, may not help you to gain industry experience.
• Search for positions but don’t apply months in advance of when you’re ready to start. If you’re finishing up a doctoral thesis, bear in mind that the company hiring CRAs is probably trying to replace a CRA who has already left the project and needs to get the new recruit trained and deployed as soon as possible. Most companies will not be able to wait for more than a month or so for a new employee to start.
• Attend NZACRes events and get networking!
• Contact [email protected] if you have further questions

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Clinical Research Associate 1

• Location: New Zealand
• Categories Clinical Monitoring
• __vacancyopjusttionswidget.opt-Business Area__ ICON Strategic Solutions
• __vacancyopjusttionswidget.opt-Remote Working __ Remote

About the role

This vacancy has now expired. please see similar roles below....

Clinical Research Associate II

Location: Auckland, New Zealand

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

• The team is highly structured and functions are very specialized, allowing you to focus solely on producing quality monitoring, building relationships with sites and taking ownership of site management
• There is a strong pipeline of studies and you will have the opportunity to monitor groundbreaking oncology trials as well as HIV, HPV and vaccine trials and work in a dynamic environment which promotes learning and versatility
• Access to advanced technologies, such as laptops and iPads , is provided. This streamlines processes allowing you to work more efficiently and for reduced report writing time meaning reports can be efficiently submitted in real time
• You will be part of an experienced and stable team which has seen huge growth and 100+ ongoing trials across Australia and New Zealand across varied therapeutic areas
• You will be joining a well-renowned sponsor program with a local reputation for having an excellent culture and offering a truly diverse and inclusive workplace
• There is a strong and passionate ICON leadership team who take a hands on approach and you will be encouraged to participate and share your ideas. The management team are supportive of career development and you will have access to external training opportunities and pathways of development

Requirements:

• At least 2 years local CRA experience in CRO/pharma is required and you will have previous experience monitoring oncology trials
• You will be based in Auckland and able to commit to travelling to sites
• Although continuous support will be provided, due to the remote nature of the role, you must be confident working autonomously to ensure delivery of expectations

Benefits of Working in ICON: Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development. At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future. ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.

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To excel as a Clinical Research Associate (CRA) in a Clinical Research Organization (CRO), you need a combination of education, skills, and the right mindset. Brazil-based CRA II Debora shares her

Brazil-based CRA II Debora Oh shares her tips on how to become a great CRA and provides insight into life at ICON.

How to progress as a Clinical Research AssociateTo thrive as a Clinical Research Associate (CRA), it is imperative to cultivate a multifaceted skill set and demonstrate unwavering commitment to exce

 Senior CRA Yemi Moses recounts her development and shares her career ambitions with ICON plc.

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Clinical Research Coordinator A/B (Department of Neuropsychiatry)

• Health, Life, and Flexible Spending Accounts : Penn offers comprehensive medical, prescription, behavioral health, dental, vision, and life insurance benefits to protect you and your family's health and welfare. You can also use flexible spending accounts to pay for eligible health care and dependent care expenses with pre-tax dollars.
• Tuition : Take advantage of Penn's exceptional tuition benefits. You, your spouse, and your dependent children can get tuition assistance here at Penn. Your dependent children are also eligible for tuition assistance at other institutions.
• Retirement: Penn offers generous retirement plans to help you save for your future. Penn's Basic, Matching, and Supplemental retirement plans allow you to save for retirement on a pre-tax or Roth basis. Choose from a wide variety of investment options through TIAA and Vanguard.
• Time Away from Work: Penn provides you with a substantial amount of time away from work during the course of the year. This allows you to relax, take vacations, attend to personal affairs, recover from illness or injury, spend time with family—whatever your personal needs may be.
• Long-Term Care Insurance: In partnership with Genworth Financial, Penn offers faculty and staff (and your eligible family members) long-term care insurance to help you cover some of the costs of long-term care services received at home, in the community or in a nursing facility. If you apply when you're newly hired, you won't have to provide proof of good health or be subject to underwriting requirements. Eligible family members must always provide proof of good health and are subject to underwriting.
• Wellness and Work-life Resources : Penn is committed to supporting our faculty and staff as they balance the competing demands of work and personal life. That's why we offer a wide variety of programs and resources to help you care for your health, your family, and your work-life balance.
• Professional and Personal Development: Penn provides an array of resources to help you advance yourself personally and professionally.
• University Resources: As a member of the Penn community, you have access to a wide range of University resources as well as cultural and recreational activities. Take advantage of the University's libraries and athletic facilities, or visit our arboretum and art galleries. There's always something going on at Penn, whether it's a new exhibit at the Penn Museum, the latest music or theater presentation at the Annenberg Center, or the Penn Relays at Franklin Field to name just a few examples. As a member of the Penn community, you're right in the middle of the excitement—and you and your family can enjoy many of these activities for free.
• Discounts and Special Services : From arts and entertainment to transportation and mortgages, you'll find great deals for University faculty and staff. Not only do Penn arts and cultural centers and museums offer free and discounted admission and memberships to faculty and staff. You can also enjoy substantial savings on other goods and services such as new cars from Ford and General Motors, cellular phone service plans, movie tickets, and admission to theme parks.
• Flexible Work Hours: Flexible work options offer creative approaches for completing work while promoting balance between work and personal commitments. These approaches involve use of non-traditional work hours, locations, and/or job structures.
• Penn Home Ownership Services: Penn offers a forgivable loan for eligible employees interested in buying a home or currently residing in West Philadelphia, which can be used for closing costs or home improvements.
• Adoption Assistance: Penn will reimburse eligible employees on qualified expenses in connection with the legal adoption of an eligible child, such as travel or court fees, for up to two adoptions in your household.

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Clinical Research Coordinator Associate

🔍 school of medicine, stanford, california, united states.

The Division of Cardiovascular Medicine , within Stanford University Department of Medicine, is a dynamic and innovative center dedicated to excellence in research, medical education, and clinical care. Our Division is driven by over 90 faculty members and a cadre of staff who are the pillar of strength in the Division's ongoing efforts into the prevention and treatment of cardiovascular disease.

We are seeking a Clinical Research Coordinator Associate (CRCA) who is passionate about clinical research and wants to deliver results. The CRCA will work with a robust clinical research team, hand in hand with Principal Investigators, Clinical Research Managers, Associates, and other stakeholders in support of cardiac patients.

The Clinical Research Coordinator Associate will be responsible for the overall implementation of an assigned set of research protocols assuring efficiency and regulatory compliance. Other responsibilities will include recruiting, screening, assisting in the informed consent process and enrolling subjects in accordance with good clinical practice guidelines as well as collecting, recording and maintaining complete data files using good clinical practice in accordance with HIPAA regulations. He/she will participate in data retrieval, reporting, and preparation of files and Case Report Forms for the various studies. Other duties may include processing of blood samples, reporting serious adverse events and maintenance of drug accountability, supplies and equipment.

CV Med Clinical Research is a growing, dynamic team who is dedicated to supporting translational medicine and contributing to Stanford Medicine’s mission. If you are eager to quickly achieve lasting results, we invite you to join our team.

Duties include:

• Serve as primary contact with research participants, sponsors, and regulatory agencies.  Coordinate studies from start-up through close-out.
• Determine eligibility of and gather consent from study participants according to protocol.  Assist in developing recruitment strategies.
• Coordinate collection of study specimens and processing.
• Collect and manage patient and laboratory data for clinical research projects.  Manage research project databases, develop flow sheets and other study related documents, and complete study documents/case report forms.
• Ensure compliance with research protocols, and review and audit case report forms for completion and accuracy with source documents. Prepare regulatory submissions, and ensure Institutional Review Board renewals are completed.
• Assemble study kits for study visits, monitor scheduling of procedures and charges, coordinate documents, and attend monitoring meetings with sponsors, acting as primary contact.
• Monitor expenditures and adherence to study budgets and resolve billing issues in collaboration with finance and/or management staff.
• Interact with the principal investigator regularly, ensuring patient safety and adherence to proper study conduct.
• Ensure essential documentation and recording of patient and research data in appropriate files per institutional and regulatory requirements.
• Participate in monitor visits and regulatory audits.

DESIRED QUALIFICATIONS:

• Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred. 

EDUCATION & EXPERIENCE (REQUIRED):

• Two-year college degree and two years related work experience or a Bachelor's degree in a related field or an equivalent combination of related education and relevant experience.  

KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):

• Strong interpersonal skills.
• Proficiency with Microsoft Office.
• Knowledge of medical terminology.

CERTIFICATIONS & LICENSES:

• Working toward certification(s) to perform basic patient measurements and tests, such as phlebotomy and EKG.  

PHYSICAL REQUIREMENTS:

• Frequently stand, walk, twist, bend, stoop, squat and use fine light/fine grasping.
• Occasionally sit, reach above shoulders, perform desk based computer tasks, use a telephone and write by hand, lift, carry, push, and pull objects that weigh up to 40 pounds.
• Rarely kneel, crawl, climb ladders, grasp forcefully, sort and file paperwork or parts, rarely lift, carry, push, and pull objects that weigh 40 pounds or more.

  WORKING CONDITIONS:

• Position may at times require the employee to work with or be in areas where hazardous materials and/or exposure to chemicals, blood, body fluid or tissues and risk of exposure to contagious diseases and infections.
• May require extended or unusual work hours based on research requirements and business needs.
• Occasional evening and weekend hours.  

WORKING STANDARDS:

• Interpersonal Skills: Demonstrates the ability to work well with Stanford colleagues and clients and with external organizations.
• Promote Culture of Safety: Demonstrates commitment to personal responsibility and value for safety; communicates safety concerns; uses and promotes safe behaviors based on training and lessons learned.
• Subject to and expected to comply with all applicable University policies and procedures, including but not limited to the personnel policies and other policies found in the University’s Administrative Guide, http://adminguide.stanford.edu/ .  

The expected pay range for this position is $31.73 - $36.54 hourly. Stanford University provides pay ranges representing its good faith estimate of what the university reasonably expects to pay for a position. The pay offered to a selected candidate will be determined based on factors such as (but not limited to) the scope and responsibilities of the position, the qualifications of the selected candidate, departmental budget availability, internal equity, geographic location and external market pay for comparable jobs.

At Stanford University, base pay represents only one aspect of the comprehensive rewards package. The Cardinal at Work website provides detailed information on Stanford’s extensive range of benefits and rewards offered to employees. Specifics about the rewards package for this position may be discussed during the hiring process.

Why Stanford is for You Imagine a world without search engines or social platforms. Consider lives saved through first-ever organ transplants and research to cure illnesses. Stanford University has revolutionized the way we live and enrich the world. Supporting this mission is our diverse and dedicated 17,000 staff. We seek talent driven to impact the future of our legacy. Our culture and unique perks empower you with:

• Freedom to grow. We offer career development programs, tuition reimbursement, or audit a course. Join a TedTalk, film screening, or listen to a renowned author or global leader speak.
• A caring culture. We provide superb retirement plans, generous time-off, and family care resources.
• A healthier you. Climb our rock wall, or choose from hundreds of health or fitness classes at our world-class exercise facilities. We also provide excellent health care benefits.
• Discovery and fun. Stroll through historic sculptures, trails, and museums.
• Enviable resources. Enjoy free commuter programs, ridesharing incentives, discounts and more.

The job duties listed are typical examples of work performed by positions in this job classification and are not designed to contain or be interpreted as a comprehensive inventory of all duties, tasks, and responsibilities. Specific duties and responsibilities may vary depending on department or program needs without changing the general nature and scope of the job or level of responsibility. Employees may also perform other duties as assigned.

Consistent with its obligations under the law, the University will provide reasonable accommodations to applicants and employees with disabilities. Applicants requiring a reasonable accommodation for any part of the application or hiring process should contact Stanford University Human Resources at [email protected]. For all other inquiries, please submit a contact form .

Stanford is an equal employment opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law.

• Schedule: Full-time
• Job Code: 1013
• Employee Status: Regular
• Requisition ID: 103289
• Work Arrangement : On Site

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