An Examination of the Role of the Clinical Research Associate and Factors Impacting Performance and Experience

The COVD-19 pandemic and changing global economies have impacted the clinical research workforce resulting in attrition, shortages, and staffing challenges. Current workforce shortages have posed numerous hurdles for clinical research stakeholders, including sponsors, investigative sites, contract research organizations (CROs), and industry associations.¹ The role of the clinical research associate (CRA) has been especially affected as high rates of turnover and vacancies proliferate. CRA turnover rates have been reported as high as 30% in the US with similar rates noted globally.²

Recent research has examined current approaches to CRA training, performance assessment, and experience. The results of a global survey of 661 clinical research professionals, including 52 CRAs, assessing their own competencies indicated that respondents with more post-secondary education reported higher levels of self-confidence in their research skills and those professionally certified by the Association of Clinical Research Professionals (ACRP) and/or Society of Clinical Research Associates (SOCRA) compared to those who were not. Self-confidence also increased with the level of academic degree.³ Researchers used a Joint Task Force (JTF) for Clinical Trial Competency Framework to assess respondents on eight competency domains. The results are consistent with prior research conducted in 2016.⁴

The JTF for Clinical Trial Competency framework as discussed by ACRP “objectively defines the knowledge, skills, and attitudes necessary for conducting safe, ethical and high-quality research.”⁵ Although common practice is currently to hire CRAs with two years of experience, high demands, vacancies, and attrition in the industry have led researchers to recognize a need to address the two years of required experience for those entering the clinical research workforce. Proposed solutions include conducting outreach to raise awareness of the profession, capturing measures of experience and transferable skills as well as add to competency-based training and innovative recruitment and retention approaches to attract candidates to the field.⁵

An examination of the entry-level shortage of CRAs cites several factors including the requirement of a minimum of two years of work experience, high CRA turnover, increasing numbers of open CRA positions, and clinical trial growth and complexity. An assessment of a monitoring simulation of 579 CRAs from a global CRO indicates no difference in performance regardless of CRA seniority and years of experience.^6,7 The research also discusses that addressing the requirement of two years of experience for CRA roles would alleviate the current shortages in the workforce.

Given the impact of the changing clinical research industry on CRAs, Tufts CSDD investigated the current role of the CRA and critical issues including shortages and turnover, and approaches to CRA training and required experience. Also, the study examined the industry practice of two years’ experience as a hiring requirement and its relationship to CRA performance and recruitment and retention practices.*

*This research study was funded by Virb, Inc.

Methodology

The research used a dual methodology comprised of a web survey of pharmaceutical, biotechnology and CRO executives and an executive roundtable with industry experts. Tufts CSDD conducted an online survey prior to the meeting to gauge perceptions and insights about the role of the CRA based on a small group of clinical research professionals from the US Areas examined included years of experience required to become a CRA and type and effectiveness of training provided. In addition, the survey gathered perceptions about CRA shortages and attrition, most successful recruitment approaches and frequently used retention strategies. CRA assessment and performance were also investigated.

A roundtable meeting was held in October 2022 with 33 participants from biotechnology and pharmaceutical companies, CROs, academia, consulting, and technology. Participants provided their insights and perceptions across a broad range of topics including CRA assessment and training and the industry standard of requiring two years of work experience as a prerequisite to hiring. Other areas explored included recruitment and retention practices; the investigative site perspective; and the impact of outsourcing models, technology, and economic factors on the CRA role.

CRA survey demographics

The survey was distributed via a link to an e-mail invitation using Qualtrics software to industry executives in the US primarily working in clinical operations or clinical development. A total of 55 responses were collected between August and September 2022. Respondents represented a mix of company types with over half (56%, n=31) representing pharmaceutical or biotechnology companies; more than one-fourth (27%, n=15) from CROs and 16% (n=9) from other company types. The mean number of company employees was 17,581 with companies ranging in size from 4 to 95,000 employees. Respondents had 21 years of experience on average and an overwhelming majority (91%, n=50) identified their functional area as clinical operations or clinical development.

CRA assessment

Survey responses varied regarding the number of years of experience required to become a CRA at respondent organizations with less than half (44%, n=15) indicating less than two years of experience, while more than one-third (35%, n=12) reporting two years of experience. A smaller percentage (15%, n=5) noted more than two years were needed, and a few respondents (6%, n=2) provided other responses. A majority (69%, n=22) reported that their organization has hired a CRA with less than two years of experience, while fewer (28%, n=9) did not or were considering this option (3%, n=1).

One area that emerged from the discussion was whether the current metrics used by organizations are useful and how to accurately measure CRA competency. The group discussed the implications of published data revealing that newer CRAs performed better on a simulation than experienced CRAs.^6,7 The results also indicated that when comparing more experienced CRAs to newer CRAs, experienced CRAs may demonstrate complacency in their roles. A meeting participant discussed the need for CRA performance metrics:

“We don’t measure much coming from CRAs. The simulation is an exciting tool. It may not be perfect, but we need something like that to give a Pass/Fail, or at least a target. Those results are miserably low. You want to see over a two-to-three-year period that your CRAs moved up in performance and then you’re looking at performance in terms of FDA audits and CRA breaches. If we don’t start, we’ll never get to that point. We’ve been looking at this for years and years.”

Using years of experience as the primary criteria for promotions and not performance was brought into question and participants discussed replacing years of experience as an overall performance metric.Although years of experience is currently the primary determinant of promotions, 61% (n=14) of respondent organizations have not examined CRA performance by CRA experience or job level, while fewer (9%, n = 2) have, with 30% (n = 7) planning to in the future. Enhanced pressure by organizations to promote top performing CRAs is common to prevent attrition. Focusing on other key performance indicators (KPIs), such as site satisfaction or evaluating soft skills acquired through maturity and experience were also proposed.

The group acknowledged that various therapeutic areas and phases of studies may pose different challenges for entry-level CRAs. For less experienced CRAs, trials in oncology, rare disease and gene therapy as well as larger phase III trials could potentially be difficult. Therefore, evaluating CRAs within the same therapeutic areas or phases or within one protocol might be more effective. Attendees also discussed giving CRAs access to their assessments, and building them into the CTMS system, so they can use them as a guide for improving their performance.

The investigative site perspective on the role of the CRA

Sites face multiple hurdles in evaluating CRA performance, one of which is achieving consistent performance given the difficulty with gathering metrics from newer CRAs. An added burden is that CRAs and site staff may lack training or specific skill sets required for their roles. Sites expect a CRA to provide a single point of contact to ensure responsiveness to inquiries despite CRAs often being overburdened with work.

One participant discussed the challenges to the CRA role on-site and the impact on studies:

“Study de-prioritization is a real thing that happens at sites. I can tell you this by experience. Calling CRAs and they never pick up the phone, it always must escalate to a director or manager and even then, they’re overwhelmed. Talking about site relationship managers, I have not seen one on any of our studies and the reason why sites de-prioritize a study is the sponsor or the CRO are absent. There are other sponsors who are more connected to the sites than other sponsors. If they aren’t responding or it’s taking too much effort, just put it in the back burner and let it sit.”

CRA turnover also impacts sites and may slow recruitment or cause study delays or terminations. Estimates of the average annual turnover rate of CRAs at organizations varied according to survey respondents. One-quarter (n=8) projected turnover between 15-20%; 22% (n=7) between 0-10%; and 16% (n=5) indicated 20-25% turnover. More than three-quarters (77%, n=23) reported that average time before turnover was more than two years.

A participant discussed “the challenge with sites is that the CRA must be the expert at all things, that resource, and it takes a CRA nine months to be proficient but they’re at a two-year cycle then that turnover is disruptive.” Senior coordinators support new CRAs and are influenced by turnover placing an even greater burden on the investigative site. A proposed solution is to have line managers work with CRAs on-site to improve rapport and teamwork.

CRA training

In examining where CRAs typically receive training, a greater percentage of survey respondents indicated CRAs were trained by academia (62%, n=21) or company training programs (59%, n=20). Nearly 40% (38%, n=13) reported that ACRP provided training, while fewer (36%, n=12) noted specific programs or other types. The remainder (21%, n=7) mentioned SOCRA or Regulatory Affairs Professionals Society (RAPS). More than one-third of respondents (33%, n=11) reported that new CRAs receive three to four months of training at their organization.

The survey also asked respondents to evaluate the most effective forms of training. An overwhelming majority of respondents (84%, n=26) reported that peer support or mentoring was the most effective training while more than three-quarters (77%, n=24) indicated in-person training was most valuable.Over half noted (52%, n=16) either observational or web-based training models were most beneficial, with 42% (n=13) reporting scenario based and 39% (n=12) experiential training. Three percent felt other trainng types were effective.

Entry-level CRA training varied at participant organizations. Some comprised large in-house training programs, while others included transitioning new college graduates from clinical study administrators to CRAs or shifting clinical research coordinators into CRA roles. Programs ranged from 12 weeks to 9 months and emphasized co-monitoring, mentoring, and training with both senior CRAs and line managers. The training also included quality assessments and use of ACRP assessments.

One participant related the details of their in-house training program:

“The demand for CRAs is growing. There’s definitely an appetite for creative ways to bring people in, we are doing that through partnership programs where you’re turning global study administrators into CRAs through a training program, including a classroom portion that is taking about three months and then actually turning into their day jobs and in another three months they’re doing on-site visits and getting that on-scene perspective.”

Companies have also established global recruitment programs for US based CRA jobs through partnerships with Mexico and Japan. A newer focus of company training emphasizes trust in partnerships. Softer skills such as communication or collaboration also comprise training and may be transferable from other roles if a candidate is new to the field.

A few alternative training approaches were proposed. One strategy included the use of chatbots for CRA questions to clarify issues and conduct training through use of behavioral data. Other methods discussed were utilizing the protocol and training documents as resources or experiential support and training.

Some general training techniques can be specifically applied to train CRAs including critical mistakes analysis of performance. This approach involves training learners on real world challenges with high stakes. Another was the use of spiral design, a training strategy intended to begin with the least complex version of a task and continue to challenge the learning with similar tasks that increase in complexity.One participant noted that “the CRA role isn’t one where individuals improve over time, but rather through training.” Attendees considered that quality of monitoring could potentially be improved through spiral learning.

Industry guidance (ICH E6R2) does not specify number of years of work experience for a CRA but stresses clinical trial specific training and experience. Nevertheless, a two-year requirement has been the industry standard and often incorporated into sponsor-CRO contractual agreements. One participant discussed that the “threshold of two years is a barrier if sponsors are not willing to take the time to train so they can provide their own help with the deficit today.” Many CROs do not have the resources to fill positions and training requires a large investment. Participants unanimously agreed that a commitment to industry training was critical.

CRA recruitment

In evaluating primary CRA recruitment approaches, larger numbers of survey respondents reported using recruiters (86%, n=25), websites or social media (69%, n=20) and staffing companies (59%, n=17). Additional approaches included professional networks or associations (45%, n=13); universities or colleges (41%, n=12); and other methods (28%, n=8). Lesser numbers recruited CRAs through training programs (24%, n=7) or conferences (17%, n=5).

The greatest number of respondents indicated recruiters (52%, n=15) were the most successful methods of recruiting CRAs while 38% (n=11) used referrals from internal staff, recommendations or appplications. Fewer(31%, n=9) reported that staffing companies, training programs (21%, n=6), professional networks or associations (17%, n=5), universities or colleges (17%, n=5) and conferences (7%, n=2) were successful.

Academic-Industry partnerships are significant to CRA recruitment and provide extensive training through internships and fellowships. Several universities have also established clinical research programs and with demonstrated success in placing students in permanent positions. A participant from a university noted:

“We focus on getting organizations to offer cooperative education opportunities which are paid internships for preparing students not just for the working environment, but also for acquiring soft skills such as preparing their resume, write their cover letters, getting in front of companies, and engaging in the dialogues of what their experiences were.”

There is, however, a pervasive lack of awareness among undergraduate students about clinical research as a profession and of the role of a CRA. In a survey of more than 200 university students in both the US and UK, not a single one had heard of clinical research as a career.⁸ Recruitment by companies on college campuses over the past five years has led to some increased awareness. A meeting participant in support of recruiting new graduates explained that “the next generation wants to work for a higher purpose and what greater higher purpose than helping humanity and saving lives?” Mentoring students is also critical however, and some universities are unable to fill faculty positions due to the massive pay disparity between industry and academia.

CRA retention and perceptions about industry shortages

The primary reasons for CRAs leaving their positions were for higher salaries (74%, n=23); followed by better growth opportunities (45%, n=14) and burnout (29%, n=9).The top two strategies implemented by organizations were flexible work schedules (65%, n=20) or higher salaries (55%, n=17).

The growth opportunities that CRAs seek are in part impacted by the rapidly changing clinical research industry and by economic factors. Both factors influence retention of CRAs and may inhibit growth opportunities. Yearly salary increases are not sustainable, and they typically leave these roles for higher paying positions.An attendee suggested that other career paths allow a CRA to stay in the industry yet be able to advance:

“We should think about as an industry, career opportunities. What else is next? Central monitoring, data monitoring, regulatory.All require quality whether or not the role is a CRA. We want to keep CRAs while promoting, because that skill set is very valuable as a monitor.”

A CRA may experience disconnectedness from staff on-site for a number of reasons: burnout from having a large work burden; working on complex studies too soon; and managing multiple technologies and systems. One participant described the gap in the support that may contribute to a CRA feeling disconnected: “there is more separation between MDs and clinical teams, and they are not connected with the CRAs on the ground.” In addition, a CRA may currently spend less time on site and more on remote monitoring.

Company outsourced models can also influence retention of CRAs. While CROs are the primary organization that staff CRAs, pharmaceutical organizations are increasingly using internal or headcount CRAs. Participants offered mixed opinions on full service, functional service provider and freelance models. One attendee with headcount CRAs reported that turnover was less than 5%, and another indicated that functional service providers (FSP) resulted in high turnover. A third participant found no differences in performance between headcount and FSP CRAs.

An overwhelming majority of survey respondents (88%, n=28) reported a shortage of CRAs in the industry while 13% (n=4) did not.Opinions were mixed about whether the shortage was getting worse (43%, n=14) or staying the same (57%, n=18), however no respondent felt the situation was improving.

Key findings and implications

The results of the survey and executive roundtable confirm that organizations are currently accommodating CRAs with less than two years of experience and establishing novel approaches to training. In addition, solutions are currently being implemented or planned to alleviate the impact of CRA shortages and turnover, and these include the following:

• Re-examining experience in relationship to performance through using innovative strategies to gather alternative metrics on CRA performance, such as evaluating site satisfaction or assessing soft skills.
  • Organizations are also planning to link specific metrics such as FDA audits to experience or job level. In addition, evaluating CRAs with similar workloads and providing access to their assessments for self-improvement are strategies being considered. Novel approaches to gathering metrics are still in the early stages of implementation, however, and follow up studies will be critical.
• Addressing the shortage of CRAs through raising awareness of clinical research as a profession at the university level.
  • Recruitment by companies on college campuses and offering university internships have led to permanent placements for students after graduation. Academic-industry partnerships also provide new graduates with valuable real-world experience before entering the workforce.
• Mentoring and working collaboratively on-site with managers can address CRA disconnectedness and facilitate teamwork as well as build trust.
  • Mentoring programs provide an increased level of support for CRAs beyond training programs. In addition, dedicated line managers working on-site offer critical training. These approaches can alleviate burnout and provide the critical groundwork for encountering challenging studies.
• Providing growth opportunities to increase retention and address issues of complacency among senior CRAs as well as offering varied incentives to remain within the industry.
  • A competent CRA can easily transition into other positions where comparable skills are valued and would be able to fill roles in regulatory, trial management, and central or data monitoring. Many organizations support career development of CRAs to increase staff retention.
• Given increasing use of technology and growth of decentralized trials, proposing sustainable solutions that tackle industry and global change is critical.
  • Solutions should address changing organizational models as well as economic factors. In response, some companies are developing in-house training programs. Other organizations are examining the impact of outsourced models on CRA performance as well as their onboarding processes and training programs to implement crucial changes to current practices.
• Consider experiential training approaches based on spiral learning that may prepare CRAs to perform effectively without two years’ experience.
  • The aviation industry trains pilots using simulation, scenarios, and real-time coaching by expert pilots and may be a useful model from which we can learn when designing curricula for training and preparing CRAs to actually monitor clinical trials in the field.

Mary Jo Lamberti, PhD, associate director and research assistant professor, Abigail Dirks, research data analyst, Robert Howie, advisory committee member, and Ken Getz, executive director and research professor; all with Tufts CSDD

References

1. Hill M. Clinical research sites share cash and workforce shortage concerns. Clinical Leader. Published online July 21, 2022.Available at: https://www.clinicalleader.com/doc/clinical-research-sites-share-cash-workforce-shortage-concerns-0001
2. Wieland A. What is really behind the CRA shortage in clinical trials? A root causes analysis. Published online May 18, 2020. Available at: https://www.clinicalleader.com/doc/what-s-really-behind-the-cra-shortage-in-clinical-trials-a-root-cause-analysis-0001
3. Sonstein S, Samuels E, Aldinger C et al. Self-assessed competencies of clinical research professionals and recommendations for further education and training. Therapeutic Innovation and Regulatory Science. 2022; 56:607-615. Published online March 31, 2022. doi: 10.1007/s43441-022-00395-z. Available at: https://rdcu.be/cY9OR
4. Sonstein S, Silva H, Thomas-Jones C et al. Global self-assessment of competencies, role relevance, and training needs among clinical research professionals. Clinical Res. 2016;30(6):42-9. Available at: https://acrpnet.org/2016/12/01/global-self-assessment-of-competencies/
5. Barriers to Bridges: Addressing the Urgent Need for a Diverse, Research-Ready Workforce within the Clinical research profession. ACRP Whitepaper. September 2022 p. 7. Available at: https://acrpnet.org/barriers-to-bridges-addressing-the-urgent-need-for-a-diverse-research-ready-workforce-within-the-clinical-research-profession/
6. Alsumidae M. Entry-level CRA shortage still crippling trials. Applied Clinical Trials. Published online March 2, 2022. Available at: https://www.appliedclinicaltrialsonline.com/view/entry-level-cra-shortage-still-crippling-clinical-trials
7. Alsumidae M. CRA Skills Lack in Critical Areas. Applied Clinical Trials. Published online May 22, 2018. Available at: https://www.appliedclinicaltrialsonline.com/view/cra-skills-lacking-critical-areas
8. Survey conducted by Connelly Partners Health for Virb, Inc., March 2022.