南京地区临床研究协调员工作质量情况调查分析  

Investigation and analysis of the quality of the work of clinical research coordinators in Nanjing

作　　者：席明名[1] 张佳佳[1] 王俐[1] XI Mingming;ZHANG Jiajia;WANG Li(Clinical Pharmacy Department,Women’s Hospital of Nanjing Medical University,Nanjing 210004,China)

机构地区：[1]南京医科大学附属妇产医院临床药学科,江苏南京210004

出　　处：《南京医科大学学报（社会科学版）》2022年第4期388-394,共7页Journal of Nanjing Medical University（Social Sciences）

摘　　要：文章旨在了解南京地区临床研究协调员(clinical research coordinator,CRC)工作质量情况,了解其工作满意度,职业状况的影响因素,以减少离职率,稳定临床试验项目团队,为提高临床研究质量提供参考依据。在咨询专家和文献分析的基础上设计问卷,对南京地区多家医院的184名CRC的工作质量进行在线调查,通过调查分析发现,CRC对工作量匹配、薪资待遇、晋升机会等工作满意度得分较低,存在较高的离职倾向,对临床试验质量有一定的影响。针对CRC的工作质量问题,需要法律法规方面明确定义、划分职能范畴,相关部门建立统一的培训考核机制、稳定的办公环境、合理的薪酬制度,进一步提升CRC的行业认可度。行政部门需采取有力措施,科学规范地培训和管理CRC;CRC也需要提升自我知识储备与工作能力,助推我国CRC行业规范化和职业化。The purpose of the article is to understand the work quality of the Clinical Research Coordinator(CRC)in Nanjing,understanding their job satisfaction,occupational status of the CRC,in order to reduce the turnover rate,stabilize the clinical trial project team,and find effective countermeasures and references basis for improving the quality of clinical research. On the basis of consulting experts and literature review,a online questionnaire was designed to investigate the work quality of 184 CRC in many hospitals in Nanjing. Through the survey analysis,it was found that CRC had a low satisfaction score on workload matching,salary and treatment,promotion opportunities,etc.,and had a high tendency to leave,which had a certain impact on the quality of clinical trials. In view of the quality of CRC’s work,it is necessary to clearly define the laws and regulations,divide the functional scope,establish a unified training and assessment mechanism,a stable office environment, and a reasonable salary system to further enhance the industry recognition of CRC. The administrative department needs to take effective measures to train and manage CRC in a scientific and standardized manner,while CRC also need to improve their self-knowledge reserves and work capabilities to promote the standardized and professional of China’s CRC industry.

关 键 词：临床试验 临床研究协调员 工作质量 

分 类 号：R197.9[医药卫生—卫生事业管理]