JTF Core Competencies

Now is the time to fix the clinical research workforce crisis

Freel SA, Snyder DC, Bastarache K, Jones CT, Marchant MB, Rowley LA, Sonstein SA, Lipworth KM, Landis SP. Now is the time to fix the clinical research workforce crisis. Clinical Trials. 2023;0(0). doi:10.1177/17407745231177885

The clinical and translational research enterprise is recognized by many as the “evidence generation system.” While there have been several calls to revolutionize this enterprise to more effectively deliver the fruits of biomedical science to patients and society, significant issues across the clinical research workforce are pervasive. Perhaps the most visible sign is the widening gap between supply and demand for competent staff. Underpinning this, is a perfect storm of complex issues. Now reaching crisis point, this problem is far bigger than a staffing issue and ultimately jeopardizes the “engine” of drug and device development. With the current perilous state of the workforce, proposed enterprise fixes are likely to languish far out of reach, given that even “business as usual” is under threat. In fact, a glaring disconnect is evident between the visionary discourse on how to revolutionize the clinical research enterprise and the sober recognition that operationalization of any such vision rests on the shoulders of a workforce that’s in dire straits. In this article, we provide a brief forensic analysis of the workforce problem and an initial indication of where solutions may lie.

Self-assessed Competencies of Clinical Research Professionals and Recommendations for Further Education and Training

Sonstein, S.A., Samuels, E., Aldinger, C. et al. Self-assessed Competencies of Clinical Research Professionals and Recommendations for Further Education and Training. Ther Innov Regul Sci 56, 607–615 (2022). https://doi.org/10.1007/s43441-022-00395-z

https://link.springer.com/article/10.1007/s43441-022-00395-z

Incorporation of Competencies Related to Project Management and Updated Clinical Trial Technology Content into the Joint Taskforce Core Competency Framework for Clinical Research Professionals

Sonstein SA, Kim LP, Ichhpurani N, et al. Incorporating Competencies Related to Project Management into the Joint Taskforce Core Competency Framework for Clinical Research Professionals. Therapeutic Innovation & Regulatory Science. 2022/01/05 2022;56(1)doi:10.1007/s43441-021-00369-7

crm-analytical-report-final.docx 

Moving from compliance to competency: A harmonized core competency framework for the clinical research professional

Sonstein SA, Seltzer J, Li R, Silva H, Jones C, Daemen E. Moving from compliance to competency: A harmonized core competency framework for the Clinical Research Professional. Applied Clinical Trials. June 2, 2014. Accessed October 3, 2024. https://www.appliedclinicaltrialsonline.com/view/moving-compliance-competency-harmonized-core-competency-framework-clinical-research-professional.