In my new role as ACRP Workforce Innovation Officer, I am focused on initiatives, products, and services intended to further develop the clinical research workforce. For those of you who know me, you know this is my passion and what I care most about. For those of you who don’t know me, I hope you will see, over the ensuing months and years, that professionalization of the clinical research profession is what drives me forward every day. I am committed to this profession and to everyone who practices in it, and I look forward to working with you and on your behalf to move the needle in clinical research education, training, and professional development. To that end, I wanted first to provide you all with an update on ACRP’s efforts to map the competencies required of clinical trial monitors.
As you may recall, ACRP released a position paper in September 2015 calling for the end of the arbitrary practice of requiring two years of monitoring experience for entry-level monitors, a practice which pretty much eliminated the monitor/clinical research associate (CRA) pipeline and resulted in an acute shortage of trained and qualified CRAs. ACRP believed, and still does today, that by focusing on competency rather than tenure, we can identify, educate, train, and prepare the future clinical research workforce.
Competence is defined as the knowledge, skills, and attributes (or attitudes) required to competently perform a task or role. In recent years, many industries and educational institutions have begun to zero in on knowledge application vs. knowledge acquisition, and have increasingly focused on competencies as a more reliable predictor of performance. Further, data from medical education programs have indicated that patient safety is enhanced by emphasizing competencies.1
Given the increased focus on competence, and the Joint Task Force for Clinical Trial Competency Framework, ACRP identified an opportunity for the industry to reconsider how it approaches workforce planning and development.
Initially, ACRP planned to work with the task force to map the entry-level competencies required of study monitors. However, after some robust discussion, the task force members determined that exercise would be incomplete, and that to do their job well, felt it was necessary to map the competencies required over the life cycle of a CRA. Therefore, they determined that they would map not only the entry-level competencies, but the intermediate, experienced, and lead CRA competencies as well.
I’m excited to say that the task force, after a one-year effort, has completed the work of mapping the competencies of CRAs using the Joint Task Force for Clinical Trial Competency Framework as the foundation. The task force also considered other competency frameworks from participating task force organizations, academic institutions, and other entities, like the International Academy of Clinical Research, a for-profit training and accreditation provider in the U.K.
ACRP will soon release the competencies for public comment through March 5, 2017. Once we’ve considered the feedback received during the public review period, we will disseminate and publicize the final competencies.
Following the dissemination of the CRA competencies, ACRP will quickly shift gears and begin working on the competencies required of site staff.
Stay tuned, you won’t believe what we have planned for 2017… you spoke, we listened!
Steinhaeuser J, Chenot J-F, Roos M, Ledig T, Joos S. 2013. Competence-based curriculum development for general practice in Germany: a stepwise peer-based approach instead of reinventing the wheel. BMC Research Notes 6:314–21.
Over the past month, ACRP has announced five new members of the multi-stakeholder ACRP Workforce Development Steering Committee. The Steering Committee is charged with reviewing and approving core competence standards for clinical research professionals developed by the ACRP Workforce Development Task Force, whose contributors include broad representation from leading industry and academic organizations across the global clinical research enterprise.
New Member Press Release Links
ACRP invites additional Steering Committee participation from executives and senior management at clinical trial sponsors. Interested parties should contact Terri Hinkley, RN, BScN, MBA, CCRC, FACRP, ACRP’s Workforce Innovation Officer, at email@example.com.