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@example.com if you have further questions