Journal of Clinical and Translational Science (Feb 2017)
Education and training of clinical and translational study investigators and research coordinators: A competency-based approach
- Nancy A. Calvin-Naylor,
- Carolynn Thomas Jones,
- Michelle M. Wartak,
- Karen Blackwell,
- Jonathan M. Davis,
- Ruthvick Divecha,
- Edward F. Ellerbeck,
- Karl Kieburtz,
- Margaret J. Koziel,
- Katherine Luzuriaga,
- Jennifer Maddox,
- Nancy A. Needler,
- Susan Murphy,
- Kieran Pemberton,
- Catherine Radovich,
- Eric P. Rubinstein,
- Harry P. Selker,
- Pamela Tenaerts,
- Kelly Unsworth,
- Kay Wilson,
- Jonelle E. Wright,
- Richard Barohn,
- Thomas P. Shanley
Affiliations
- Nancy A. Calvin-Naylor
- Institute for Research on Innovation and Science (IRIS), University of Michigan, Ann Arbor, MI, USA
- Carolynn Thomas Jones
- College of Nursing, Ohio State University, Columbus, OH, USA
- Michelle M. Wartak
- Broad Institute of MIT, Tufts University, Boston, MA, USA
- Karen Blackwell
- Human Research Protection Program, University of Kansas, Kansas City, KS, USA
- Jonathan M. Davis
- Frontiers: The Heartland Institute for Clinical and Translational Science, University of Kansas, Fairway, KS, USA
- Ruthvick Divecha
- Medical Affairs, University of Michigan, Ann Arbor, MI, USA
- Edward F. Ellerbeck
- Department of Preventive Medicine and Public Health, University of Kansas, Kansas City, KS, USA
- Karl Kieburtz
- Clinical and Translational Science Institute, University of Rochester, Rochester, NY, USA
- Margaret J. Koziel
- UMass Center for Clinical and Translational Science, University of Massachusetts, Lowell, MA, USA
- Katherine Luzuriaga
- UMass Center for Clinical and Translational Science, University of Massachusetts, Lowell, MA, USA
- Jennifer Maddox
- Frontiers: The Heartland Institute for Clinical and Translational Science, University of Kansas, Fairway, KS, USA
- Nancy A. Needler
- Clinical and Translational Science Institute, University of Rochester, Rochester, NY, USA
- Susan Murphy
- Michigan Institute for Clinical & Health Research, University of Michigan, Ann Arbor, MI, USA
- Kieran Pemberton
- Frontiers: The Heartland Institute for Clinical and Translational Science, University of Kansas, Fairway, KS, USA
- Catherine Radovich
- Michigan Institute for Clinical & Health Research, University of Michigan, Ann Arbor, MI, USA
- Eric P. Rubinstein
- Clinical and Translational Science Institute, University of Rochester, Rochester, NY, USA
- Harry P. Selker
- Clinical and Translational Science Institute, Tufts University, Boston, MA, USA
- Pamela Tenaerts
- Clinical Trials Transformation Initiative, Durham, NC, USA
- Kelly Unsworth
- Human Subject Protection Program, University of Rochester, Rochester, NY, USA
- Kay Wilson
- Michigan Institute for Clinical & Health Research, University of Michigan, Ann Arbor, MI, USA
- Jonelle E. Wright
- Clinical and Translational Science Institute, University of Miami, Miami, FL, USA
- Richard Barohn
- Frontiers: The Heartland Institute for Clinical and Translational Science, University of Kansas, Fairway, KS, USA
- Thomas P. Shanley
- Department of Pediatrics, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA
- DOI
- https://doi.org/10.1017/cts.2016.2
- Journal volume & issue
-
Vol. 1
pp. 16 – 25
Abstract
Introduction Training 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. Methods Clinical and Translational Science Awards representatives refined competency statements. Working groups developed assessments, identified training, and highlighted gaps. Results Forty-eight competency statements in 8 domains were developed. Conclusions Training 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.
Keywords
