The Professionalization of the Clinical Trial Industry

Clinical Researcher—March 2021 (Volume 35, Issue 2)


Erika Stevens, MA


Does the clinical trial industry need to do more to professionalize itself?

While the clinical research enterprise aids the development of novel clinical therapies, the occupations supporting these roles are unidentified by the Bureau of Labor Statistics (BLS). Neither clinical research associates (CRAs) nor clinical research coordinators (CRCs) are classified by the BLS. Members of ACRP, however, readily recognize these key roles and others as parts of the workforce keeping complex clinical trials moving safely and efficiently throughout the clinical research lifecycle.

Whether officially recognized by the BLS or not, CRCs, CRAs, and others perform critical tasks enabling the advancement of new healthcare treatments; yet the lack of recognition by the BLS impedes the industry in defining critical metrics, such as the size of the workforce or hiring trends.

ACRP is leading the way in raising awareness of this problem and offering some possible solutions. Among these efforts are initiatives aimed at defining key roles within the clinical research industry, mapping the competencies for job performance, providing education/training critical to these jobs, and validating clinical research workforce capability. We also need to work toward establishing greater standardization through the industry to help attract new talent, while at the same time retaining among us the best and the brightest.

ACRP will continue to be a catalyst committed to elevating the clinical research workforce both in terms of performance and as a profession. ACRP is committed to educating leaders in government and to partnering with professionals at the National Institutes of Health and other organizations to advance clinical research certifications. As Chair of ACRP’s Association Board of Trustees for 2021, I am dedicated to supporting these initiatives to drive the professionalism of the clinical research industry.

I look forward to working closely with you, the members of ACRP, on these and other exciting endeavors the rest of this year and beyond.

I wish you all the best jusqu’a la prochaine fois (until the next time),

Erika Stevens, MA, has more than 20 years’ experience in the research industry, is the 2021 Chair of the Association Board of Trustees for ACRP, and leads Transformation Advisory Solutions for Recherche Transformation Rapide. She advises life sciences companies, health systems, academic medical centers, foundations, hospitals, and contract research organizations in process improvement initiatives for quality and efficiency in operations, cross-functional relationships, administration, manufacturing, and compliance. Her earlier volunteer duties with ACRP include service as Chair of the Editorial Advisory Board, a member of the Conference Planning Committee, and President of the New York Metropolitan Chapter.