The role and challenges of clinical research coordinators: insights from a national survey

临床研究协调员的角色和挑战:一项全国性调查的启示

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Abstract

BACKGROUND: Clinical research coordinators (CRCs) play a vital role in the management and execution of clinical trials, particularly in oncology and hematology. METHODS: This survey-based study, conducted by the Italian Group of Data Managers and Clinical Research Coordinators (GIDMcrc), explores the responsibilities, job satisfaction and training needs of CRCs across Italy. RESULTS: 171 professionals from 20 Italian regions participated in the survey. The results indicate that CRCs predominantly engage in data management, monitoring and regulatory tasks, with significant involvement in activities such as patient registration, data entry and compliance with ethical requirements. However, discrepancies between actual job responsibilities and formal job descriptions were common, leading to reported dissatisfaction regarding workload and training adequacy. Despite the challenges faced, the majority of respondents expressed overall job satisfaction, although just under half of respondents are considering transitions to Clinical Research Organizations (CROs) or pharmaceutical companies due to better opportunities. CONCLUSIONS: This study highlights the critical need for clearer job definitions and enhanced training programs for CRCs to improve their effectiveness and job satisfaction within the evolving landscape of clinical research. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12874-025-02687-y.

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