Standing on the outside of a profession and looking in is no easy thing. Without access to “insider’s knowledge” about how to pursue a career path in which you are interested, how do you even know in which direction to take the first step? For example, many people who are just beginning to explore different roles in clinical research find the duties of a clinical research associate (CRA) very attractive (on paper, at least). However, they may not realize immediately that very few applicants for a CRA position with a sponsor or contract research organization (CRO) will be hired straight into a monitoring role without first having worked as a clinical research coordinator (CRC) for a site or as a clinical trial assistant (CTA) for a sponsor.
In a forthcoming peer-reviewed article for ACRP’s Clinical Researcher journal, Anthony Chew, a clinical trial operations professional and recent graduate of the MS program in Medical Product Development Management at San Jose State University, describes CRAs as serving as “the primary liaison between the sponsor and the site by monitoring and verifying data to ensure accuracy and adherence to protocols. They collaborate with investigators, conduct site visits [including for site feasibility/selection and validation/qualification purposes followed by study initiation and ongoing monitoring], and maintain strict documentation to guarantee the integrity of a trial.”
As part of his graduate studies, Chew surveyed current and former CRAs to learn about their professional backgrounds, the types of employers that initially hired them, the training processes they underwent as new CRAs, and any advice they had for aspiring CRAs. Among the respondents, experience in the clinical research field ranged from two years to more than 25 years, with an average experience of nine years in the field. Nearly half of the respondents held their first CRA job with a CRO, whereas most of the rest began at a sponsor organization and just a handful began at an academic institution/hospital.
Notably, more than two-thirds of respondents were observed to have held positions as CRCs or CTAs prior to becoming CRAs. At the most basic level, CRCs support, facilitate, and coordinate daily research activities on the site end; CTAs provide administrative and project tracking support for clinical trials on the sponsor end.
“Among the respondents who were former CRCs, almost one-third cited their experience as CRCs to have played a major role in helping become an effective CRA,” Chew writes. “Respondents who had experience as a CTA also indicated its benefits.”
According to one of the respondents to Chew’s survey, “I do think one benefit of being a CRC is that if you’re interested in going into the medical field, that can be a really good bridge, because you’re working with patients and physicians in a clinical setting. But…there isn’t quite as much room for [direct] upward mobility” for CRCs at a site. On the other hand, CTAs might be promoted into a CRA position without having to leave their current employer.
Chew notes that characteristics related to “communication skills” and “attention to detail” were listed by most respondents as important for being an effective CRA. He also writes that “the purpose of this survey was not to provide a definitive judgment of where or how CRAs are hired, but rather, to point the aspiring CRA in the ‘general direction’ and offer insight as to the advantages and disadvantages that each type of experience provides. While there is no ‘wrong’ pathway to become a CRA, the responses would suggest that the ideal pathway is to start out as a CRC, then join a large CRO as a full-service alignment CRA [working on multiple trials for different sponsors at once], and then to secure a CRA position with a sponsor. This pathway optimizes the ability for the potential candidate to receive as much experience as possible. …Obviously, this is easier said than done.”
Respondents who did not have CRC or CTA experience before becoming CRAs mentioned networking, continuing education, and having a background in such duties as working in a laboratory, handling clinical samples, and demonstrating an ability to adhere to the protocols for trials as useful, Chew wrote.
“Clinical research is still a developing field, and while the pathway to becoming a CRA can be frustrating, the experiences [noted by current and former CRAs in this survey demonstrate] that persistence can pay off,” Chew concludes.
The full article by Chew will appear in the August 2024 issue of Clinical Researcher.
Resources
Association of Clinical Research Professionals—Ready, Set, Clinical Research!
ACRP Certified Clinical Research Associate (CCRA®) Certification
ACRP CRA Core Competency Foundations(TM) Training Program
Career Navigation in Contract Research Organizations: A Vignette from Clinical Researcher (August 2023)
Available in the Course Catalog as ACRP 2024 Study & Site Management session replays (login required):
A Crash Course in the Basics of Clinical Trial Monitoring
Fixing Feasibility: Collaborative Approaches for Redefining and Improving Site Selection
Site Qualification Visits: From “The First Date” to Going Steady
Site Validation/Qualification Visit: Picking the Right Sites
Available in the Course Catalog in the ACRP 2024 Workforce Development session replays (login required):
A CRA Training Program for Overcoming Workforce Development Roadblocks
Available in the Course Catalog in the ACRP 2024 Leadership & Professionalism session replays (login required):
A Holistic CRA Evaluation Process for Improving Monitoring Visits
Edited by Gary Cramer
