Moving from Compliance to Competency: A Harmonized Core Competency Framework for the Clinical Research Professional

By CenterWatch
Published: June 2014

By Stephen A. Sonstein, Ph.D., Eastern Michigan University; Jonathan Seltzer, M.D., MBA, MA, FACC, ACI Clinical; Rebecca Li, Ph.D., Harvard University; Carolynn Thomas Jones, DNP, MSPH, RN, University of Alabama at Birmingham; Honorio Silva, M.D., ACRES; Esther Daemen, MBA, RN, ACRP
Published: June 2014

For physician investigators, CRCs and CRAs, there are certification programs which are highly regarded, but there are no formal regulations which define the educational or experiential requirements to conduct clinical research. This paper will discuss the newly formed Joint Task Force for Clinical Trial Competency (JTF) and its work towards creating a single, high-level set of standards which could serve as a framework for defining professional competency throughout the clinical research enterprise.

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