背景: 随着中国医药研发的快速发展，政策激励促使企业研发投入不断攀升，新药研发进程加快，临床试验数量显著增加。与此同时，临床试验的质量要求和监管力度不断提高，监查员作为核心角色，其专业性和效率要求也日益提升。既要确保试验的高效推进，又要严格把控质量，满足高标准要求。然而，在高强度、快节奏的工作环境下，监查员的心理健康可能受到影响，职业倦怠风险增加。因此，关注监查员的职业状态具有重要的意义。

目的：了解临床试验监查员心理弹性、工作满意度、职业倦怠的现状，发现其特点和问题，探究监查员心理弹性、职业倦怠、工作满意度的影响因素，考察监查员心理弹性、工作满意度和职业倦怠之间的相互关联。

方法：使用由基本情况表、心理弹性量表、中文版MBI-GS量表以及明尼苏达满意度短式量表所构成的调研问卷，以便利抽样的方式，针对在职临床试验监查员展开调查，最终回收得到302份有效的问卷。通过运用SPSS 27.0统计软件，对所收集的数据实施描述性统计、单因素分析、相关性分析、回归分析以及中介效应检验等操作，以探究监查员心理弹性、工作满意度与职业倦怠之间的内在关联机制。

结果：

1.监查员心理弹性总分（88.05±15.90）。在年龄、学历、专业、工作年限、月收入以及婚姻状态上，其心理弹性水平呈现出显著差异（P＜0.05）。

2.监查员工作满意度总分（68.43±12.32）。在年龄、专业和月收入方面，监查员的工作满意度得分存在显著差异（P＜0.05）。

3.监查员职业倦怠检出率64.24%，总分（40.04±15.31）。在学历、专业、就职公司和周平均工作时长等方面，监查员的职业倦怠得分存在显著差异（P＜0.05）。

4.相关性分析的结果上，监查员心理弹性与工作满意度之间存在正相关关系（P＜0.01），且心理弹性和工作满意度都与职业倦怠呈现负相关关系（P＜0.01）。

5.依据中介效应分析结果，监查员工作满意度在心理弹性与职业倦怠的关系中发挥了部分中介的作用，其中直接效应值为-0.236，该效应占比47.45%，间接效应值为-0.262，效应占比为52.55%。

结论：

1.研究表明监查员的心理弹性总体处于中等偏上水平，工作满意度则处于中等水平，超六成以上的监查员存在不同程度的职业倦怠。

2.心理弹性对监查员的工作满意度具有显著的正向预测作用，即心理弹性水平越高，工作满意度也越高。且心理弹性和工作满意度均对职业倦怠产生负向影响，表明心理弹性和工作满意度的提升有助于缓解职业倦怠。

3.工作满意度在监查员的心理弹性和职业倦怠之间发挥部分中介作用，心理弹性可用过工作满意度来降低职业倦怠。

Background: With the rapid development of pharmaceutical research and development in China, policy incentives have prompted enterprises to continuously increase their drug research and development investment, accelerate the process of new drug development, and significantly increase the number of clinical trials. At the same time, the quality requirements and regulatory strength of clinical trials are constantly increasing, and as the core role of CRA(Clinical Research Associate), their professionalism and efficiency requirements are also increasing. Need to ensure the efficient progress of the experiment while strictly controlling the quality to meet high standard requirements. However, in high-intensity and fast-paced work environments, the mental health of CRA may be affected, and the risk of occupational burnout may increase. Therefore, paying attention to the professional status of inspectors is of great significance.

Objective: To understand the current status of psychological resilience, job burnout, and job satisfaction of clinical research associate, identify their characteristics and problems, explore the influencing factors of psychological resilience, job satisfaction, and job burnout of CRA and examine the interrelationships among the psychological resilience of CRA, job satisfaction, and job burnout.

Methods: Using a questionnaire composed of basic information form, Psychological Resilience Scale (CD-RISC), MBI-GS scale, and Minnesota Satisfaction Questionnaire (MSQ), a convenience sampling method was adopted to conduct a survey among on-the-job clinical research associate. Finally, 302 valid questionnaires were obtained. Through the application of SPSS 27.0 software, descriptive statistics, one-way analysis, correlation analysis among the three, regression analysis and mediation effect test are implemented for the collected data to explore the internal mechanism among CRA psychological resilience, job burnout and job satisfaction.

Results：

1.      The total score of psychological resilience of the CRA was (88.05 ± 15.90) . There are significant differences in age, education level, profession, working years, monthly income, and marital status (P < 0.05).

2.      The total score of  job satisfaction of the CRA was（68.43±12.32）. There are significant differences in age, profession, and monthly income (P < 0.05).

3.      The detection rate of  job burnout among CRA is 64.24%, with a total score of (40.04±15.31). There are significant differences in education level, profession, company of employment, and average weekly working hours (P < 0.05).

4.      The correlation analysis indicates that the resilience of CRA is positively associated with their job satisfaction. (P < 0.01), and psychological resilience and job satisfaction are both negatively correlated with job burnout (P < 0.01).

5.      According to the results of mediation effect, the job satisfaction of CRA acts as a partial mediator in the relationship within psychological resilience and burnout, with a direct effect value of -0.236, accounting for 47.45%, and an indirect effect value of -0.262, accounting for 52.55%.

Conclusion：

1.      The research shows that the overall psychological resilience of CRA is at a medium to high level, while job satisfaction is at a medium level. More than 60% the CRA have different degrees of job burnout.

2.      Psychological resilience has a significant positive predictive effect on the job satisfaction of CRA, that is, the higher the level of psychological resilience, higher the job satisfaction. Moreover, psychological resilience and job satisfaction both have a negative impact on job burnout, indicating that the improvement of psychological resilience and job satisfaction helps to alleviate job burnout.

3．Job satisfaction serves as a partial mediator in the relationship within the psychological resilience and burnout of CRA. Specifically, psychological resilience can mitigate job burnout through the pathway of enhanced job satisfaction.