Core Competencies for Clinical Research Professionals

Clinical Researcher, June 2014

I have been a key opinion leader in developing core competencies for clinical research professionals through collaborations with two key groups (the CoAPCR and Joint Task Force for Harmonized Core Competencies). The initial work was developed through the Consortium of Academic Programs in Clinical Research (CoAPCR). This group studied existing work in clinical research core competencies. I led a publication on these core competencies and the establishment of CoAPCR approved competency domains and associated KSA activities (Knowledge, Skills & Attitudes) for clinical research professionals. The CoAPCR has an interest in defining competencies for the purpose of establishing educational standards for the accreditation of academic programs in clinical research (Certificates, Associate Degrees, Baccalaureate Degrees and Master’s Degrees). Building upon the published work of the CoAPCR (Jones et al, 2012) members of the CoAPCR (including myself) and other stakeholders formed the Joint Task Force for Harmonized Clinical Research Competencies. It was felt that Core Competencies should address the full-range of stakeholders and had applications beyond informing curricula, but had far reaching applications such as: job titles, job descriptions, performance evaluations, site accreditation standards, among other things. Another publication based on the evolved Harmonized Core Competencies by Sonstein et al, 2014 was simultaneously published in four key clinical research publications: Clinical Researcher (ACRP), Applied Clinical Trials, Centerwatch White Papers and Journal of Clinical Research Best Practices (MAGI). In January, 2015, I presented a Poster on the Core Competencies in Mumbai, India at the OSU-India Health Sciences Innovation Conference.

Research and Impact

As a founding member of The Joint Task Force, we are continuing to research and validate the core competencies and plan to submit results of a global survey we conducted.

Several groups have now begun to adopt the JTF Framework:

CoAPCR
- A variety of Academic Programs in Clinical Research, including The Ohio State University MACPR program have mapped their curriculum to the JTF Framework.
  - [OSU, George Washington University, Campbell University, Arizona State University, Drexel University, University of North Carolina-Wilmington, among others]
Commission on Accreditation for Academic Programs in Clinical Research
Association of Clinical Research Professionals (ACRP)
UK National Health Service Workforce Development Group
NCATS- CTSA
Healthcarepoint/ACRES
Duke University- Piloting mapping clinical research job titles and descriptions, training and evaluation parameters to the JTF Framework

This list continues to grow in number and we are often called upon to speak and present on the competencies. One interest I have is in establishing eportfolios and a badge system for clinical research professionals that will enable individuals to document KSAs in each of the competency domains through a blue-cloud-based system. This connects professionals to stakeholders and potential agencies, institutions and sponsors for future employment or collaboration. The impact of the JTF Core Competencies is being heralded as one of the major impacts to clinical research workforce. To manage a centralized clearinghouse of JTF activities and initiatives, the Association of Clinical Research Professionals (ACRP) has agreed to host the group, including launching an independent website. A recent video of one of our JTF members, Terri Hinkley, Interim Executive Director of ACRP can be found here: http://blog.mdsol.com/acrps-terri-hinkley-on-the-changing-roles-of-cras/

Please see additional information on linking the JTF Framework to a clinical research nursing framework.

Fairhope Docks, Carolynn Thomas Jones