临床监查员的职业任务现状

Cross-sectional study on occupational roles of CRA

目的：评价临床监查员（CRA）的职业任务现状。方法：采用CRA职业任务调查问卷,对200名CRA的工作任务数量、任务适应情况以及对研究机构的满意程度进行调查。结果：共回收176份有效问卷。有效问卷中,女性占71.6%,年龄范围在21~42岁,平均年龄（28.76±3.97）岁。77.9%有医学或药学教育背景,本科及以上学历占87.0%。在任务数量方面,接受调查的CRA中80.2%负责1～3个项目,66.0%负责3～8个中心,77.8%每月监查天数在5 d以上,83.0%每月出差不超过2次,79.5%每周工作40～60 h;被调查对象中49.4%和41.0%分别认为较常或经常面临受试者入组和数据清理的时限性任务,83.5%认为基本能够在时限内完成监查报告。在任务适应方面,77.8%的被调查对象有2年以上临床监查经验,50.5%对薪酬基本满意,69.8%对新的工作机会有兴趣,50.0%和56.2%分别在1周内曾经接到过猎头的电话和曾经至少更换过一次工作;82.4%对直线经理的支持和指导比较满意。在对研究机构满意度方面,33.6%的CRA认为研究中心较常或经常有临床研究协调员（CRC）协助完成工作;46.6%认为研究者具有较好的临床试验质量管理规范（GCP,Good Clinical Practice）知识;71.6%和65.4%的CRA分别认为研究者和CRC较合作或完全合作,但66.5%认为用于督促研究中心完成研究任务的时间占工作时间的20%以上;25.0%和24.5%的被调查对象分别对伦理委员会和临床试验机构较满意或完全满意。结论：CRA每天工作时间相对较长,较常面临受试者入组或数据清理的时限性任务。市场对CRA和CRC的需求仍处于较高的水平。CRA对研究者的GCP知识和合作基本满意,但仍用较多时间督促研究中心完成研究任务。CRA对伦理委员会和临床试验机构的满意程度不高。

Objective： To evaluate occupational roles of CRA （clinical research associate）. Methods： A total of 200 CRAs participated survey for task numbers, role sufficiency and satisfactory status with investigational site by Clinical Research Associate Occupational Roles Questionnaire. Results： 176 questionnaires were collected and evaluable. 71.6% were females, the average age was 28.76 ± 3.97 with range of 21 to 42, 77.9% of the CRAs had medicine or pharmacy background, and 87.0% had a bachelor or master degree. With regard to role loading, 80.2% of the CRAs handled 1 to 3 projects, 66.0% handled 3 to 8 sites, 77.8% monitored on site at least 5 days per month, 83.0% traveled no more than twice per month, and 79.5% worked 40 to 60 hours per week. 49.4% and 41.0% of the responders thought they often faced to subject recruitment and data clean time-lines. 83.5% of the CRAs could complete monitoring visit report （MVR） within timelines. In terms of role suffi- ciency, 77.8% of the responders had 2 years monitoring experiences or more, 50.5% were generally satisfied with pay and benefits. 50.6% and 55.6% of the CRAs respectively received call（s） from headhunter for new job opportunities and changed job at least one time. As to satisfactory status toward investigational sites, 33.6% of the CRAs indicated clinical research coordinators （CRC） were available to help them at site. 46.6% thought investi- gators had good GCP （Good Clinical Practice） knowledge. 71.6% and 65.4% thought investigators and CRCs were cooperative, but 66.5% thought they spent at least 20% of their time to persuade site to complete tasks. Only 25.0% and 24.5% of the responders felt satisfactory with IRB/ECs and GCP centers. Conclusion： CRAs worked longer daily hours, and usually faced to subject recruitment and database clean timelines. There were still high demands for CRAs and CRCs in the market. CRAs were generally satisfied with investigator′s GCP knowledge and cooperation, but less satisfied with IRB/ECs and GCP centers.