By Beth Harper
I am fortunate for many reasons, not the least of which is the two professional hats that I get to wear. As ACRP’s workforce innovation officer I focus on initiatives aimed at growing, diversifying, and enhancing the competency of the clinical research workforce. In my consulting capacity I help teams optimize enrollment and site performance in their trials, which inevitably involves a lot of site and clinical research associate (CRA) training. It’s the intersection of these roles, particularly as it relates to the responsibilities of the CRA, that is a focus of this article.
Ask any project team, or CRA for that matter, what the expectations are for this role and you’ll get vastly different answers. For many, the CRA is an all-knowing, all-purpose expert whose responsibilities cover a broad range of responsibilities, including:
- Site selection and qualification
- Study feasibility
- Site training
- Study operations and implementation
- Subject enrollment oversight and support
- The single point of contact for a site
- Study initiation, management, and close-out
- Study monitoring
For others, the CRA role is more focused on the monitoring and compliance aspects of study conduct, but this also varies based on where the CRA works. While typically the role of a clinical research coordinator (CRC) or study coordinator is linked to someone working at an investigative site, and a CRA or study monitor is associated with someone working at a sponsor or CRO, this is not always the case. CRAs can work for sponsors, CROs, as well as sites, which further adds to the confusion about the role and expectations. As such, the job titles differ significantly. In fact, a recent CRA job analysis revealed over 50 different related job titles and over 500 associated knowledge, skills, and abilities required of CRAs across some 102 tasks within 12 competency domains.1 How likely is it that one individual embodies all of these competencies or could successfully perform all these tasks with excellence across multiple trials?
Interestingly, ICH GCPs and federal regulations only speak to the monitoring requirements in terms of stipulating that the sponsor should:
- Ensure that the trials are adequately monitored,
- Determine the appropriate extent and nature of monitoring, and
- Select monitors qualified by training and experience to monitor the progress of the investigation.
The term CRA is not mentioned in regulatory guidance documents outside of a brief reference to CRAs in the context of clinical monitors.2 For the purposes of this article, therefore, we’ll focus on the CRA who is employed by the sponsor or CRO as opposed to those CRAs working at investigative sites.
Ramifications Of The Lack Of Standardized Titles And Role Expectations
Broadly speaking, this lack of standardization in job titles and responsibilities results in a number of challenges for the industry, from creating job descriptions, hiring profiles, and training plans, to benchmarking salaries and defining career advancement paths, to high levels of turnover and burnout rates.
At the granular level, unrealistic expectations for CRAs can have a significant impact on study performance. Consider this frequent scenario. The site has a potential subject but is unclear about whether they qualify for the study. The CRC calls the CRA, who may or may not be available because they are off monitoring another trial or performing other tasks. When the CRC finally reaches the CRA (which could be days later), the CRA – who isn’t familiar with the details of the study (because they are working on multiple trials, even though they are expected to be the protocol expert) – tells the CRC they need to get back to them. The CRA reaches out to the lead CRA or regional CRA, who in turn reaches out to the study team and, ultimately, the medical monitor for clarification. The feedback eventually reaches the site personnel, but the window of opportunity to enroll the interested subject has long since passed. Wash, rinse, and repeat this cycle for multiple sites within and across studies and it’s no surprise that sites become frustrated and discouraged and ultimately stop trying to identify and enroll subjects for a trial. Or even worse, the CRA shows up to conduct the site initiation visit (SIV) but because they can’t possibly know the details of multiple studies, or aren’t adequately trained themselves, they proceed to read the 180 SIV slide training deck (a.k.a., death by PowerPoint march), which is not only ineffective from a site training perspective but sets the CRA-site relationship off to a bad start. The site staff have no confidence in the CRA as their single point of contact for protocol and eligibility related questions, so they don’t even bother to enroll for the trial. You get the idea. It’s no wonder then, that the site stops taking calls or doesn’t respond to the obligatory calls/emails from the CRA inquiring “how many subjects have you screened this week?” The cycle continues and then the study finds itself in “rescue mode.”
Is this the fault of the CRA? Absolutely not! It’s a failure of our systems, training, and expectations that haven’t set the CRA or the site up for success if we expect the CRA to be the expert on everything across multiple trials. Not to mention, the way CRAs are trained is often less than effective. This is why every time I hear study teams’ default to “just have the sites call the CRA” as the universal solution for every site enrollment or other study implementation question, it makes me cringe.
An Opportunity Emerges
Certainly, some organizations (larger sponsors and CROs) have created specialty roles, such as study start-up specialists, budget and contract experts, site relationship managers, and other functions, but this is not always a feasible option for many smaller organizations. Recognizing that we will never find a one-size-fits-all solution, we do have an opportunity to clearly define the title and clarify expectations that could go a long way to addressing some of the challenges. What if we traded the term CRA for clinical research monitor (CRM)? As monitoring is a regulatory requirement, it would be clear that a CRM (whether in a centralized monitoring or field monitoring role) is fulfilling the monitoring function. Training and expectations for CRMs could be focused on developing true monitoring competencies, which are quite distinct from many of the other tasks an all-purpose, traditional CRA might fulfill. This would go a long way to standardizing job descriptions, expectations, and salaries. A CRM who has honed their monitoring expertise could more easily grow to senior roles and transfer to a different company. The new employer, in turn, would have realistic expectations about the role the CRM could fulfill, whereas today CRAs are clearly not created equally in terms of their capabilities. The CRA term could still be reserved for roles that do all sorts of other roles related to study design, setup, and conduct, while separating out the monitoring responsibilities and delegating these specifically to the CRM.
Further work would need to be done to standardize the non-monitoring-focused CRA and other roles and titles (e.g., clinical research project managers and equivalent), but at least everyone would have clear expectations and understanding about the role of the CRM.
ACRP is embarking on a new project to reevaluate CRA competencies and expand our current Clinical Trial Monitoring competency guidelines.3 It’s particularly important to get the expectations of CRAs/CRMs clearly defined as protocols become increasingly more complex, trials become more virtual, and monitoring practices shift from on-site to more centralized approaches.4
The first step is conducting a CRA workforce development and advancement survey (https://www.surveymonkey.com/r/CRASurvey2020). The results will inform the work of our task force that will define the competencies and tackle the role, title, and expectation challenges. We welcome your participation as a volunteer and/or your feedback on the survey. Regardless of whether we gain consensus on the proposed CRM terminology or come up with something more relevant (or profound!), we’re overdue for rethinking the role of a CRA who plays such a critical role and contributes so much to the success of a clinical trial.
- Certified Clinical Research Associate (CCRA) Job Analysis review performed by ACRP 2019-2020
- FDA Guidance for Industry: Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring. Retrieved from: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/oversight-clinical-investigations-risk-based-approach-monitoring
- Patil, R. The Clinical Trial and CRA of the Future. Retrieved from: https://www.iqvia.com/library/white-papers/the-clinical-trial-and-cra-of-the-future
About The Author:
Beth Harper is the president of Clinical Performance Partners, Inc., a clinical research consulting firm specializing in enrollment and site performance management. Harper also is the workforce innovation officer for the Association of Clinical Research Professionals (ACRP). She has passionately pursued solutions for optimizing clinical trials and educating clinical research professionals for over three decades. Harper is an adjunct assistant professor at George Washington University who has published and presented extensively in the areas of protocol optimization, study feasibility, site selection, patient recruitment, and sponsor-site relationship management. She serves on the CISCRP Advisory Board and the Clinical Leader Editorial Advisory Board, among other industry volunteer activities. Harper received her B.S. in occupational therapy from the University of Wisconsin and an M.B.A. from the University of Texas. She can be reached at 817-946-4728, firstname.lastname@example.org, or email@example.com.