Empirical study on the core competencies of clinical research coordinators
ZHANG Bang-yu
JIANG Yi-dan
ZHANG Ling
Abstract：Objective:Clinical research coordinator(CRC)play a critical role in the implementation of clinical trials.Therefore,there is an urgent need for effective assessment tools to measure CRC's competence in fulfilling their responsibilities.Methods:This study developed a competence model for CRC through literature research,questionnaire surveys,and expert consultations.The model's validity was evaluated using Pearson correlation analysis,exploratory factor analysis,and confirmatory factor analysis.Additionally,the reliability was tested using Cronbach's α coefficient and Spearman-Brown split-half coefficient.Results:The final model consisted of three factors and twenty indicators.The three factors included professional competence,project management practices,and ethics and subject safety.This three-factor model aligns with the theoretical framework of knowledge,skills,and attitudes in competence models.The results of both exploratory and confirmatory factor analyses indicated that the model has good structural validity.The overall Cronbach's α coefficient was 0.965,and the Spearman-Brown split-half reliability coefficient was 0.899,indicating high reliability of the model.Conclusion:The study identified the core competencies of CRC in the Chinese clinical trials setting,providing a scientific basis for the evaluation,assessment,education,training,and management of CRC,as well as a practical evaluation tool for their professional development.
Keywords：clinical research coordinatorindicator systemcompetenceempirical study
Publication Date：2025-10-30
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：6( 2203-2208 )