Developing a Strategic Approach to Drive Training Excellence for Clinical Research Professionals

Purpose: To evaluate and assess the current training models in relation to the core knowledge and skills requirements for clinical professionals specifically of Clinical Research Associates (CRAs) and Clinical Research Coordinators (CRCs). Hypothesis: Current training of CRAs and CRCs is inadequate due to a number of reasons. Teaching core necessary research skills is a basic foundation for the development of specific training models for CRAs and CRCs. Design: Study modules and training presentations were created for the purpose of teaching the company’s standard operating procedures (SOP) to MedTrials Employees. Research journal articles were searched for roles of CRAs and CRCs. The data gathered helped identify and analyze training gap seen between research professionals. Results: Roles of CRCs proved to be multiple and varied between sites and trials. CRAs tasks were more stable and mainly involved having expertise in the overall process of clinical trials. However, both positions showed a necessity to improve their current model of training.