The Clinical Research Coordinator: Perception of Roles, Responsibilities, and Competence

Abstract

Due to the nature of risk in clinical research, patient harm may result; therefore, it is essential to mitigate the risks ensuring the safety of participants and the integrity of clinical research. Recent changes in the clinical research environment have resulted in delegation of tasks, previously assigned to Clinical Research Nurses (CRNs), to Unlicensed Clinical Research Coordinators (ULCRCs) without knowledge of potential consequences. This project describes interprofessional Clinical Research Coordinator’s (CRC’s) perceptions of roles, responsibilities, and competence in implementing clinical research activities of varying complexity, including similarities and differences of the CRN CRC and the ULCRC. Current literature describes the role, activities, and value of the CRN CRC. However, the literature lacks evidence to explore the impact on delegated work of the ULCRC. Using snowball sampling, CRCs in the United States were invited to complete an anonymous, investigator created, online survey. After meeting inclusion criteria, CRCs were asked to answer questions related to their role and responsibilities as a CRC, and rate clinical research activities related to domains of their role (clinical practice, study management, care coordination and continuity, and human subject protections), for frequency performed, appropriateness to role, and confidence in performing. Of 215 completed surveys, 91 (42.3%) identified as a CRN CRC and 124 (57.6%) as ULCRCs. CRCs, regardless of licensure, report similar work settings, populations served, types of studies supported, and categories of activities performed. The CRN CRC performed clinical research activities across all domains of practice more frequently than ULCRCs and rated all domains as more appropriate to their practice with higher confidence than the ULCRCs. In addition, ULCRCs reported performing activities that are outside of their scope, such as administering study medications intravenously. CRCs reported often feeling there is more work than is appropriate and training is inadequate; leaving the potential for some CRCs to take on activities perceived as inappropriate or outside their scope of practice and lacking in competence to complete the activity. These findings add to the literature by systematically describing interprofessional CRCs perceptions of their roles, responsibilities, and competence in implementing clinical research activities of varying complexity.