院外临床研究协调员现状分析及优化对策探讨

Current work situation of out of hospital clinical research coordinators and optimization strategy

目的对临床研究协调员(CRC)工作现状进行调查分析,提出针对现状不足之处的优化和改进建议。方法采用线上问卷对上海市23家临床试验机构中第三方临床机构管理组织(SMO)公司派驻的院外CRC进行问卷调查。结果CRC人员以女性为主(91.09%);年龄集中在25~29岁(50.78%);大多拥有护理学专业背景(49.61%)。CRC职业认同均分为66.45分,在职业认同的5个维度中,CRC职业社会认知的均值最高,职业自我反思均值最低。工作满意度均值为33.51分,其中内在满意的均值最高,55.18%的CRC有考虑过离职。在考虑离职的288人中,64.24%是因为收入不符合期望,升职概率小。在工作中,CRC会面临试验项目难度的挑战、项目执行过程中的困难、CRC自身专业能力薄弱等多方面困难。结论通过调查,明确了当前院外CRC工作现状与职业发展瓶颈,针对CRC紧缺现状及其职业发展困境等现实问题,从国家、行业和个人3个方面提出对策建议。

Objective To investigate the current work situation of clinical research coordinators(CRCs)and to offer proposals for optimization and improvement.Methods An online⁃questionnaire was used to survey the out⁃of⁃hospital CRCs assigned by Site Management Organization(SMO)in 23 clinical trial sites in Shanghai.Results CRCs were mainly female(91.09%)and 50.78%of the employees aged between 25 and 29 years old.Most CRCs(49.61%)had a nursing background.The average score of CRC professional identity was 66.45.Among the five dimensions of professional identity,the mean score of CRC occupational social cognition was the highest,while the mean score of occupational self⁃reflection was the lowest.The mean score of job satisfaction was 33.51,and the mean score of intrinsic satisfaction was the highest in the three dimensions of job satisfaction,and 55.18%CRCs had considered turnover.Among the 288 people considering turnover,64.24%were due to income not meeting expectations and a low chance of promotion.CRCs faced various difficulties such as difficulty in trial projects,difficulties in project execution,and weak professional skills.Conclusion Current status and career development bottleneck of out⁃of⁃hospital CRCs are clarified through the investigation.And countermeasures and suggestions are put forward from three aspects,including the state,profession and individuals in view of CRC shortage and its career development dilemma.