The role of clinical trial nurses: Transitioning from clinicians to clinical research coordinators

Aims This study aimed to explore the role of clinical research coordinators (CRCs) and identify the importance and performance of the role as well as the factors that affect the professional recognition of their role. Methods A total of 102 CRCs from 10 hospitals were recruited for a survey. The Clinical Trial Nursing Questionnaire scale developed by Ehrenberger and Lillington was used to collect data for the importance-performance analysis. The importance and performance data were plotted on a two-dimensional grid, and multiple stepwise linear regression analysis was used to determine the influencing factors on the CRC role. Results The influencing factors on the importance of the CRC role were frequency of protocol assessment, implementation and evaluation and professional nursing role performance. The influencing factors on performance were formal education and training in clinical research, institutional career ladder system for professional development and identification as a principal investigator in research studies. The influencing factor on the professional nursing role perception was the lower component of the 'performance of professional nursing role'. Conclusion Formal educational preparation, identification as a principal investigator in research studies and clear career progression are supportive factors to the professional recognition of CRC as a specialized nursing role. Summary statement What is already known about this topic? Clinical trials ultimately contribute to improving public health. A clinical trial process should cover a number of tasks, such as provision of study information to patients, recruitment of patients, screening and obtainment of their consent. Clinical trial nurses affect the quality of clinical trials, but little is described about the scope and contribution of their roles in clinical trials. What is already known about this topic? This study explored the role of clinical research coordinators (CRCs) and their professional role recognition in the wake of policy changes in South Korea since 2015. Formal education, role delineation and career ladder schemes are critical factors to the career advancement of CRCs, as shown in the study results. Identifying the changes and effects of the relevant policy has implications to the South Korean context and beyond, serving as a reference for countries considering setting up CRC roles or establishing an educational system for CRCs. The implications of this paper: Formal education, role delineation and career ladder schemes are critical factors to the career advancement of CRCs. To improve the performance and professional awareness of CRCs, a government-led system and policies on formal education and career ladder are needed so that CRCs can fulfil their role in improving public health.