中国临床药学杂志

目的 分析上海地区临床研究协调员（CRC）职业现状，从CRC视角研究临床试验质量的影响因素与质量管理面临的挑战，并提出“区域性CRC中心”管理模式设想。方法 向常驻上海的CRC发放调研问卷，问卷内容包括CRC的职业背景、培训情况、项目资源配置情况、工作压力与职业发展。结合调研结果与工作实际情况，分析CRC面临的主要问题及其对临床试验质量的潜在影响。结果 CRC中本科学历占70.50%，大专学历占28.78%；护理专业占53.24%，医学专业占7.19%；工作年限≥5年的仅占6.48%;96.40%CRC接受过岗前培训，58.27%CRC实践培训时长不足1月；78.42%的CRC工作不到半年就开始独立负责项目，39.57%的CRC同时负责3～4项临床试验；CRC工作压力值≥5分占83.46%,56.83%的CRC认为“与试验相关各方沟通”是工作难点，21.58%的CRC有强烈跳槽意愿。结论 CRC在职业素养、工作能力、培训考核、项目资源配置和工作压力等方面存在明显的个体差异，给临床试验质量带来潜在风险。优化CRC管理模式和资源配置，提高CRC的职业素养与业务能力，以及强化CRC队伍的专业性和稳定性，是提升临床试验质量的关键。

AIM To analyze the occupational status of clinical research coordinators(CRC) in Shanghai, investigate the influencing factors of clinical trials and the challenges faced by quality management from the perspective of CRC, and propose a management model of "regional CRC center". METHODS A survey was to be distributed to CRC, currently based in Shanghai, covering aspects such as their professional background, training status, project resource allocation, work pressure, and career development. By integrating the survey findings with actual working conditions, the key challenges faced by CRC and their potential impact on the quality of clinical trials were analyzed. RESULTS CRC with a bachelor's degree accounted for 70.50% of the survey cohort. In comparison, 28.78% of CRC held a college degree, 53.24% majored in nursing, and 7.19% majored in medicine. Additionally, only 6.48% possessed no less than 5 years of work experience. And, 96.40% of CRC had received pre-job training, yet 58.27% had undergone practical training that lasted less than a month. Furthermore, within 6 months of starting work, 78.42% of CRC began to manage projects independently, and 39.57% of CRC were responsible for managing 3 to 4 clinical trials simultaneously. The survey revealed that 83.46% of CRC reported work stress levels ≥ 5(out of 10), 56.83% identified "communicating with all parties related to the experiment" as their primary challenge, and 21.58% expressed strong intentions to switch jobs. CONCLUSION CRC has significant gaps in professional ethics, work ability, training and assessment, project resource allocation, and work pressure, which poses potential risks to the quality of clinical trials. Optimizing CRC management mode and resource allocation, improving the professional competence and business ability of CRC, and enhancing the professionalism and stability of the CRC team are key to improving the quality of clinical trials.