Through my involvement in managing clinical research personnel, and developing and conducting clinical research education and training, I have gained a keen interest in the specific “competencies” required for clinical research professionals.
- What competencies do clinical research professionals need to have?
- How can we better describe roles and differentiate job titles for clinical research professionals?
- How do we evaluate staff in these newly evolving roles?
- Who should be delegated which responsibilities in operating a clinical research site and study?
- How can individuals progress and move upwards in their clinical research careers?
- How can these roles become more professionalized?
- What should be included in initial training of clinical research staff?
- What are continuing education needs?
- What degree paths should individuals pursue?
- What are the roles for nurses and those who are not nurses in clinical research jobs?
- What should an undergraduate and graduate curriculum consistently include as coursework?
The pivot point for these questions is the patient! How can clinical trials operate efficiently, safely, ethically and provide scientifically sound answers to complex medical questions. Since the onset of my clinical research career in the mid 80s I have witnessed remarkable changes in federal regulations, globally accepted guidelines, international trials and studies that are increasingly complex.
I have been proud to align myself with like-minded professionals who were also on the quest for best practice and competency development. Through my work with colleagues in the CoAPCR and the Joint Task Force for Clinical Research Competency, 8 primary domains for clinical research competency have evolved. This work revealed 8 domains and 51 distinct competencies distributed across those domains. The work was published in an article in clinical researcher (Sonstein et al, 2014). This portfolio is using the 8 domains as a structure for this ePortfolio:
- Scientific Concepts & Research Design (5 competencies)
- Ethical and Participant Safety (8 competencies)
- Medicines Development & Regulations (7 competencies)
- Clinical Trials Operations (12 competencies)
- Study & Site Management (6 competencies)
- Data Management & Informatics (5 competencies)
- Leadership & Professionalism (4 competencies)
- Communication & Teamwork (4 competencies)
Each of the competencies identified in each domain are generalized topics, which could easily be broken down into several more granular assessments of knowledge, skills and abilities (KSAs). Each role and career path may lean more heavily on specific sets of competencies. Professional Organizations, such as Regulatory Affairs Professionals (RAPS) and IACRN have identified specific competencies that encompass their professional membership roles. Usually those competencies can be mapped to the 8 domains.
Since the publication of our paper, the JTF Framework has been adopted by groups domestically and internationally for personnel job descriptions, organizational training, professional association certifications and academic program curriculum mapping.