临床研究协调员工作质量情况调查分析
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南京市妇幼保健院

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Investigation and analysis of the clinical research coordinator work quality
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Women’s Hospital of Nanjing Medical University

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    摘要:

    摘要:本次研究用文献分析法以及问卷调查法,问卷填写人员为在临床试验机构中工作的临床研究协调员(CRC),目的是为了了解和提高CRC的工作满意度,减少职业倦怠,减少离职,稳定临床试验项目团队,为最终提高临床研究质量找到有效的对策和参考依据。目前CRC行业缺乏行业认同度,部分CRC薪资与工作强度不相匹配,同时CRC本身缺乏法律法规方面明确的定义以及职能范畴的划分,缺乏统一且具有权威性的培训及考核制度,进一步导致CRC出现缺乏职业认同,薪资与工作量不匹配等情况。为进一步提升CRC工作质量,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行业更规范化、更职业化、更好的发展。

    Abstract:

    Abstract: Literature analysis and questionnaire survey were used in this study. The questionnaire was filled by the clinical research coordinator clinical trial institution. The purpose was to improve the job satisfaction of CRC, reduce job burnout, reduce turnover, stabilize the clinical trial project team, and find effective countermeasures and reference basis for improving the quality of clinical research. At present, CRC industry is lack of industry identity, some CRC salaries do not match the work intensity, at the same time, CRC itself is lack of clear definition of laws and regulations, division of functional categories, lack of unified and authoritative training and assessment system, which further leads to lack of professional identity, salary and workload mismatch, etc. In order to further improve the quality of CRC work, the administrative departments need to take effective measures to train and manage CRC scientifically and normatively. CRC also needs to improve its own knowledge reserve and working ability to promote the more standardized, more professional and better development of CRC industry in China.

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  • 收稿日期:2022-04-20
  • 最后修改日期:2022-05-10
  • 录用日期:2022-05-26
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