Education and training of clinical and translational study investigators and research coordinators: A competency-based approach

Author:

Calvin-Naylor Nancy A.,Jones Carolynn Thomas,Wartak Michelle M.,Blackwell Karen,Davis Jonathan M.,Divecha Ruthvick,Ellerbeck Edward F.,Kieburtz Karl,Koziel Margaret J.,Luzuriaga Katherine,Maddox Jennifer,Needler Nancy A.,Murphy Susan,Pemberton Kieran,Radovich Catherine,Rubinstein Eric P.,Selker Harry P.,Tenaerts Pamela,Unsworth Kelly,Wilson Kay,Wright Jonelle E.,Barohn Richard,Shanley Thomas P.

Abstract

IntroductionTraining for the clinical research workforce does not sufficiently prepare workers for today’s scientific complexity; deficiencies may be ameliorated with training. The Enhancing Clinical Research Professionals’ Training and Qualifications developed competency standards for principal investigators and clinical research coordinators.MethodsClinical and Translational Science Awards representatives refined competency statements. Working groups developed assessments, identified training, and highlighted gaps.ResultsForty-eight competency statements in 8 domains were developed.ConclusionsTraining is primarily investigator focused with few programs for clinical research coordinators. Lack of training is felt in new technologies and data management. There are no standardized assessments of competence.

Publisher

Cambridge University Press (CUP)

Reference19 articles.

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3. Alignment of Competencies to Address Inefficiencies in Medicines Development and Clinical Research: Need for Inter-Professional Education

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