Page 25 - 《中国药房》2022年3期

重庆市临床研究协调员/临床监查员的工作流动性现状和对策

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曹丽亚 ，陈勇川 ，郭 薇 ，谢林利 （1.陆军军医大学第一附属医院药剂科，重庆 400038；2.重庆医科大学附
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属口腔医院临床研究中心，重庆 400038）
中图分类号 R95 文献标志码 A 文章编号 1001-0408（2022）03-0275-05
DOI 10.6039/j.issn.1001-0408.2022.03.04

摘 要 目的 了解重庆市临床研究协调员（CRC）、临床监查员（CRA）的工作流动性现状，探讨提高CRC、CRA工作稳定性的可行
方法。方法 以问卷形式对重庆市22家药物临床试验机构的200名CRC和 CRA进行工作流动性情况调查，内容涉及人员基本情
况、工作流动性情况、流动原因等方面。结果与结论 回收有效问卷178份，有效回收率89.00％，其中CRC问卷回收110份，CRA
问卷回收68份。被调查的CRC和CRA中，主要为20～30岁的年轻人，分别占各职业人群的87.27％、82.35％；CRA学历水平整体
略高于CRC；所学专业和既往工作经历主要以医药相关为主，其他非医药相关职业转行从事CRC的比例高于CRA。CRC工作年
限在3年以内的占88.18％，其中具有1～＜3年的工作经验后，既往工作单位数量在2个及以上的占50.00％；CRA工作年限在3年
以内的占64.70％，其中具有1～＜3年的工作经验后，既往工作单位数量在2个及以上的占70.37％。CRC平均每人经手临床试验
项目5.38项，完成1.22项；CRA平均每人经手7.47项，完成2.04项。CRC和CRA跳槽或离职的主要原因包括薪资低于期望、晋升
机会少、工作量太大，分别占各职业人群的83.64％/80.88％、45.45％/39.71％、31.82％/26.47％。作为临床试验中的重要组成部分，
CRC、CRA工作流动性较大。建议建立统一的行业标准，规范CRC、CRA的管理权责，同时优化CRC、CRA的工作模式，提高职业
认同感和归属感，从而提高相关从业人员的工作稳定性。
关键词 临床研究协调员；临床监查员；工作流动性；临床试验

Status quo and countermeasures of job mobility among clinical research coordinator/clinical research
associate in Chongqing
CAO Liya ，CHEN Yongchuan ，GUO Wei ，XIE Linli（1. Dept. of Pharmacy，the First Affiliated Hospital of
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Army Medical University， Chongqing 400038， China； 2. Clinical Research Center， the Affiliated
Stomatological Hospital of Chongqing Medical University，Chongqing 400038，China）
ABSTRACT OBJECTIVE To investigate the job mobility of clinical research coordinators （CRCs） and clinical research
associates（CRAs）in Chongqing，and to explore the feasible methods to improve the job stability of CRCs and CRAs. METHODS
Questionnaire survey was conducted to investigate the job mobility of 200 CRCs and CRAs working in 22 drug clinical trial
institutions of Chongqing. The contents included basic information， job mobility， and reasons for mobility. RESULTS &
CONCLUSIONS Totally 178 valid questionnaires were recovered，with an efficient recovery rate of 89.00％，of which 110 were
recovered from CRCs and 68 were recovered from CRAs. Among the surveyed CRCs and CRAs，the age distribution was mainly
20-30 years old，accounting for 87.27％ and 82.35％ of the respective population respectively. The overall educational degree of
CRAs were slightly higher than those of CRCs. The majors and previous work experience were mainly related to medicine；the
proportion of other non-medicine-related professions who switched to CRCs was higher than that of CRAs. Totally 88.18％ had
CRC working experience within 3 years；after having 1-＜3 years of work experience，50.00％ had worked in 2 or more work
units. Totally 64.70％ had CRA working experience within 3 years；after having 1-＜3 years of work experience，70.37％ had
worked in 2 or more work units. CRCs handled 5.38 items of clinical trials and completed 1.22 items on average；CRAs handled
7.47 items and completes 2.04 items on average. Main reasons of CRCs and CRAs for job-hopping included low salary below
expectations，few promotion opportunities，and too much workload，accounting for 83.64％/80.88％，45.45％/39.71％，31.82％/
26.47％，respectively. As an important part of clinical trials，CRCs and CRAs had high job mobility. It is suggested to establish a
unified industry standard，standardize the management rights and responsibilities of CRCs and CRAs，optimize the working mode
of CRCs and CRAs，and improve professional identity and sense of belonging，so as to improve the job stability of relevant
employees.
＊主管药师，硕士。研究方向：药理学、药物临床试验机构管理。
电话：023-68766776。E-mail：caoliya008@163.com KEYWORDS clinical research coordinator；clinical research
# 通信作者：主管药师。研究方向：药物临床试验机构管理。电 associate；job mobility；clinical trial
话：023-68766775。E-mail：24310479@qq.com

中国药房 2022年第33卷第3期 China Pharmacy 2022 Vol. 33 No. 3 ·275 ·