Objective: To explore the mutual influence of clinical research coordinator(CRC) occupational identity, job burnout and turnover intention, and provide a theoretical basis for the effective management of CRC through structural equation model simulation. Methods: A survey of 505 CRCs inside and outside Zhongda Hospital was conducted by using the basic situation questionnaire, occupational identity rating scale, job burnout scale, and turnover intention questionnaire. Through AMOS 24.0 and SPSS 24.0,the statistical analysis of each variable and the establishment of structural equation model were carried out. Results: The majority of CRC groups were unmarried and childless women under the age of 30 dispatched by site management organization(SMO) companies, mainly in medicine(including clinical medicine and nursing) and pharmacy. Structural equation model showed that occupational identity of CRC significantly negatively predicted turnover intention(βdirectly=-0.29, P<0.001) and job burnout(βdirectly=-0.64, P<0.001); occupational burnout significantly positively predicted turnover intention(βtotal=0.33, P<0.001); CRC's professional identity indirectly affects turnover intention through job burnout(βindirectly=-0.21, P<0.001). Conclusion: Clinical trial institutions should start with the establishment of unified management procedures, systematic training programs, sub-discipline management models and establishment of a comprehensive assessment system to enhance CRC professional identity while reducing job burnout, effectively reducing turnover intentions. These are important pathways to stabilize research teams, and ensure high-quality, high-efficiency, and stable clinical trials. |
[1] CFDA进一步加强药物临床试验数据自查核查[J].中国医药导刊,2015,17(12):1279.
[2] MASCARO J S,PALMER P K,ASH M J,et al. Feasibility, acceptability, and preliminary effectiveness of a compassion-centered team intervention to improve clinical research coordinator resilience and well-being[J]. JCO Oncol Pract,2021,17(7):e936-e946.
[3] 曹富林,王维,张利,等.医学生职业认同现状及影响因素研究[J].卫生职业教育,2021,39(23):118-121.
[4] 黄燕妮,贺立华,汤雪英.基层急诊护士职业倦怠现状调查及其影响因素分析[J].甘肃医药,2021,40(10):936-937,940.
[5] 杨雪,孙超.护士感知的管理关怀现状及其与职业倦怠、离职意愿的关系[J].中国护理管理,2021,21(8):1226-1230.
[6] 刘玲.护士职业认同水平及其与工作压力、职业倦怠的相关研究[D].上海:第二军医大学,2009.
[7] 李小妹,刘彦君.护士工作压力源及工作疲溃感的调查研究[J]. 中华护理杂志, 2000, 35(11): 645-649.
[8] 李栋荣,李经远.矩阵式组织结构下角色冲突, 组织承诺, 离职意愿关联性研究[D].新竹: 国立交通大学管理科学研究所, 2000: 9-13.
[9] 张茹,方惠娟,周艳芝,等.兰州市三甲医院护士职业压力职业倦怠与离职倾向的关系[J].中国妇幼保健,2022,37(4):684-688.
[10] 段应龙,吴小霞,钟竹青,等.护士职业认同、职业倦怠对离职意愿影响的研究[J].中国护理管理,2017,17(3):368-373.
[11] 李丽清,赵玉兰,李佳文,等.全科医生工作满意度、离职意愿与职业倦怠的结构方程模型研究[J].中国卫生统计,2021,38(2):286-289.
[12] 郑航.我国临床研究协调员职业专业化发展研究[D].天津:天津大学,2017.
[13] 郑佳冰,陈玉玲,施小勇.药物临床试验临床研究协调员工作现状调查分析[J].海峡药学,2021,33(11):223-225.
[14] 沈勇刚,陈丽丽,叶嘉俊,等.临床研究协调员(CRC)现状的调查分析[J].今日药学,2022,32(10):796-800.
[15] 侍培培,张全,孙明敏,等.医疗机构临床研究协调员的管理现状[J].中国临床药理学杂志,2023,39(7):1046-1049.
[16] 黄倩,刘健,吴丽花.基于医疗机构视角的临床研究协调员现状分析及管理优化探讨[J].中国新药与临床杂志,2021,40(4):270-272.
[17] 李惠军.临床试验质量保障关键因素之一——中国临床研究协调员的职业倦怠现象浅析[J].中国食品药品监管,2022,217(2):100-107.
[18] 杨雪,孙超.护士感知的管理关怀现状及其与职业倦怠、离职意愿的关系[J].中国护理管理,2021,21(8):1226-1230.
[19] 邹燕琴,陈娜,吕丽虹,等.构建药物临床试验机构CRC管理体系[J].今日药学,2023,33(1):77-80.
[20] 张邦禹,李玉平,张鹏,等.中国临床研究协调员压力源特征研究[J].中国新药杂志,2020,29(15):1752-1756.
[21] 曹丽亚,陈勇川,谢江川,等.重庆市临床试验机构研究协调员培训现状分析[J].中国药业,2022,31(9):23-26.
[22] 邱佳玲,李锦粤,范潇茹,等.基于主客体互依中介模型分析成对数据中的中介效应[J].中国卫生统计,2021,38(5):679-682. |