Interview: Everything you need to know about becoming a clinical research associate (CRA)

OSP: What are the reasons behind the increased global demand for clinical research associates (CRAs)?​

SB: There has been an intensified shortage in the clinical research industry for experienced clinical research associates (CRAs) as the demand has significantly outpaced supply over the past two decades. For example, in 2018, the industry had a global shortage of over 17,000 CRAs due to the rising demand for well-trained, experienced CRAs.

This demand has continued to increase for a variety of reasons, the most prominent being the steady increase in the number of clinical trials being initiated year over year.  According to ClinicalTrials.gov, by the end of 2000 they reported just 2,119 registered clinical trials compared to the end of 2022 when they reported 437,540 clinical trials.  More studies equal more demand for CRAs.

Another factor contributing to the increased demand for CRAs is that many large pharma sponsors use large, embedded sourcing models to enable a variable workforce. Many of these are multiple supplier models, which results in the sponsor making requests for a CRA to all suppliers simultaneously, amplifying the demand significantly. In a three-supplier model in the same market, the market itself will reflect a demand for three CRAs even though that demand traces itself back to the single request by the sponsor.

OSP: How does ICON address this challenge when hiring?​

SB: The number of years of experience is often the determining factor used by sponsors, and indeed CROs, to determine whether or not to hire a CRA. These time-based experience requirements are only one of the levelling considerations: we prioritise competency and skill, which are a large part of the levelling process.

Sponsors often specify that they need highly experienced CRAs, a group that is often scarce. In our experience, prescribed levels of experience for CRAs are in fact related to the competence of a CRA. The industry has been working under the implied assumption that CRA experience is the only indicator of CRA competence.

We have not found this to be the case. Yes, experienced CRAs are highly valuable, but through practical training, mentoring, and performance and metrics management, CRAs with less than two years of experience can often perform at that same level or higher than CRAs with more experience. And so, we have made a shift from competing with the demand for CRAs to investments in the supply of CRAs.

To address the supply challenge ICON has been delivering foundation training for new, inexperienced CRAs for almost a decade. By 2015, as demand for CRAs skyrocketed across the industry, we began significantly investing in this program with the understanding that the supply we were creating would be beneficial to the industry. Since then, we have introduced over 3,000 new CRAs into the clinical research industry via our comprehensive training program. ​

OSP: What kind of practical training and mentoring do you offer your early-career CRAs?​

SB: We don’t adopt a one-size-fits-all approach. In fact, we run a number of dedicated CRA training programs. One such program is our CRA Bridge Program, which is a comprehensive training program that provides core CRA foundation training, practical application, extensive mentoring and coaching. The Bridge CRAs undergo competency assessments to ensure that they are equipped to excel. The program has been designed to provide maximum retention of training material coupled with comprehension checks to ensure knowledge transfers into performance.

Our talent pool for the CRA Bridge Program typically includes study coordinators, research nurses, pharmacists and nurse practitioners amongst others. These individuals join ICON with a wealth of experience and the ability to develop strong, interpersonal, and credible relationships with site staff.

Another valuable resource pool for our CRA Bridge Program is our in-house CRA resources, those with experience on the CRO side of research, albeit from the perspective of the study management side. These resources develop into strong CRAs and, through additional soft skills development and structured mentoring, quickly learn the equally valuable knowledge needed for success.

With the increasing prevalence of decentralised clinical trials, enabled by telehealth visit checks, wearable technology for the study's patients, and new ways of monitoring data and patient safety, the next generation of CRAs will need to be fully tech-fluent, comfortable working in remote environments and become stewards of the data as the lines between clinical research associate and data manager start to blur. Experienced CRAs will need to adapt and move on from the old ways of working. Our Bridge CRAs are leaping to the front of this new paradigm as they join without any other frame of reference. They are ready to learn without having to first unlearn.

OSP: What are the performance indicators used to understand if the CRAs the company hires are competent even if they lack a given number of years of experience?​

SB: Our Bridge CRAs not only complete competency checks throughout their training, they also complete an intense and comprehensive mentorship that requires they observe – and perform – each task associated with each monitoring visit type prior to be allowed to conduct a monitoring visit independently.  Once they earn their sign-off to monitor independently, they receive a Quality Oversight Visit within the first 6 months of independent monitoring.  This allows ICON to identify any skills that still need support and can address them early on.  Approximately one year after completing their CRA Bridge training, the Bridge CRA completes a comprehensive monitoring assessment that allows them to showcase their knowledge and year of experience while giving ICON a clear picture of their monitoring competencies.

Additionally, for three years following their CRA Bridge training, we isolate the performance and quality metrics of the Bridge CRAs and compare them to their more experienced peers, looking for any indicators that additional support might be needed. Instead of discovering gaps, however, the Bridge CRAs have consistently shown that their performance is on a par with the more tenured CRA, proving again that experience does not always determine competence.

Through all of these activities to track and monitor our Bridge CRAs, we have found no significant differences in the performance between the Bridge CRAs and their more experienced peers, which once again reinforces that tenure does not always mean greater competence.  

OSP: What has the company learned from such an approach to hiring and investing in staff?​

SB: As we developed this particular training program, our hypothesis was that we would have higher staff retention with our Bridge CRAs in comparison to other experienced members of staff, largely due to experienced CRAs having less professional time remaining in the role before wanting to move on to the next phase of their career. We also expected to show that the performance of these staff would be similar to the performance of our experienced CRA team members. Both of these hypotheses have been proven to be true.

Our approach to investing in our staff has resulted in the economic benefits of hiring these less-tenured CRAs and the benefits of lower turnover and demand pressure for this typically scarce resource. The benefits have not been accompanied by the increased risk typically associated with using less experienced CRAs, particularly as we replace experience with competence as an entry qualification. The shift in investment focus from competing with the demand for CRAs to investments in the supply of CRAs has generated material benefits for sponsors and ICON alike.