Abstract:Objective To understand the self-evaluation of clinical research knowledge among clinical research coordinators（CRC）and clinical research associates（CRA），and to explore their influencing factors，in order to provide reference for conducting high-quality CRC/CRA training. Methods A multi-stage cluster sampling method was employed to select 400 CRC/CRA from four municipal hospitals in Shanghai as study participants. From October to December 2023，data were collected via an online questionnaire（Questionnaire Star）using a self-designed survey covering basic information，self-assessed knowledge of clinical research，and training needs. Statistical analysis was performed on the collected data.Results A total of 378 valid questionnaires were collected，including 187 from CRC and 191 from CRA. Significant differences were observed between CRC and CRA groups in gender，age，education level，major，and years of experience（P<0.05）. The self-evaluation score for clinical research knowledge was 35.76±5.30，with the highest scores in document recording and management，clinical trial data management，and informed consent. CRC group scored higher than CRA group in subject management and clinical trial data management（P<0.05）. Multivariate linear regression analysis showed that professional background and the number of ongoing clinical trials were major influencing factors（P<0.05）.Conclusion CRC and CRA exhibit suboptimal familiarity with clinical research knowledge. As key contributors to clinical research，it is essential to establish unified qualification standards，develop a comprehensive knowledge training system，and enhance their competency to ensure the quality of clinical research.