In this peer-reviewed article, authors Joseph M. Bocchino, EdD, Joan Butler, EdD, MS, and Beth Harper, MBA, BS (OT), review the literature addressing the current state of education within the clinical research profession to ascertain directions in which the profession and its supporting educators may be moving in order to further develop clinical research workforce capacity.  The importance of competency-based education and the JTF Core-Competency Framework are highlighted.

Duke University’s Office of Clinical Research has been on the forefront of utilizing the JTF Core competency Framework to define its role descriptions as well as to clearly specify how a clinical research professional can move upwards on their career ladders.  Their recent publication through the Society of Research Administrators International (SRAI), Volume LI, Number 2 explains these processes in detail.  The authors conclude that the utilization of the JTF Framework in this manner has benefited the institution by increasing CRP retention rates and allowed Duke to better understand current competency levels of its workforce.  Duke University’s Office of Clinical Research and their utilization of the JTF Core Competency Framework has been a model for the academic community and their efforts have been utilized by several of the Clinical and Translational Science Award institutions.

A paper appearing in the Journal of Clinical and Translational Research reported on a study by the International AIDS Malignancy Consortium which assessed the competency level and role relevance of the JTF Core Competencies in Clinical Investigators from Sub-Saharan Africa and Latin America.  The results indicated that the highest relevance to role was in the Scientific Concepts and Research Design and the Ethical and Participant Safety domains and the lowest in the Data Management and Informatics domain.  A high level of self-assessed competency was seen in the Ethical and Participant Safety domain, but lower levels of self-assessed competency were seen in the Data Management and Informatics and the Scientific Concepts and Research Design domains.   An additional domain, Community Engagement, was added to the framework by the investigators due to the perception of increased relevance in the assessed geographic regions, though interestingly, this domain showed a high level of competence, but a low level of role relevance.  The AMC is working to incorporate professional development offerings to investigators based upon the results of this assessment.

Our Japanese colleagues have published the Joint Task Force Core Competency Framework in the Japanese Journal of Clinical Pharmacology and Therapeutics (2020;51(3):131-150). This publication in the Japanese language helps extend the integration of the Framework to clinical research professionals in Japan.

The Association of Clinical Research Professionals (ACRP) announces a pilot project designed to assess the competency of entry-level clinical research professionals, ACRP’s hypothesis is that new graduates from academic programs in clinical research will pass the ACRP-CP exam at equal or higher rates than individuals with a minimum of 2 years’ experience in clinical research. If proven true, then providing graduating students access to an ACRP-CP certification exam will enable the further demonstration of their knowledge and competency thereby enhancing a hiring organization’s confidence in recruiting, training, and retaining these new graduates as valuable members of their research teams. The Consortium of Academic Programs in Clinical Research has been working for some time with ACRP to develop this program.  Three institutions are participating in the program, Campbell University, University of North Carolina Wilmington and Durham Technical Community College.

A recent publication reports that investigators from the Clinical and Translational Science Award based DIAMOND project have developed and tested indices which may be used to evaluate the self-assessed competency of clinical research coordinators.  The two indices, CICRP-I (basic level) and CICRP-II (advanced level) were developed using data selected from the JTF Global Self-Assessment of Clinical Research Competency.  The CICRP-II assessment was administered to 95 clinical research coordinators working in one of 4 CTSA funded academic health centers in an effort to accumulate data which could be used to confirm the validity of the instrument and compare the results to similar assessments which were published by the JTF that self-assessed the competency of a variety of members of the global clinical research enterprise.

A recent publication by faculty from the University of Georgia and Emory University described a study of how the JTF Core Competency Domains are perceived by clinical research coordinators as relates to their career orientation and career satisfaction.   Different aspects of the role of clinical research coordinator define certain career orientation types.  Four different types were identified utilizing a web-based survey.  The conclusion of the study was that “understanding the career orientation of CRC’s can be helpful to institutional administrators and clinical investigators as they support professional development and training of CRC’s.