【 Main Responsibilities and Duties 】主要职责和任务 : 1) Responsible for the selection and evaluation of research centers and confirmation of study units and investigators prior to the trial.负责研究中心的选择及调研评估，试验前确认研究单位及研究者。 2) Monitor clinical trials of MD / IVD reagents. Properly manage the documentation, research products, and financial issues of the research center.进行医疗器械/体外诊断试剂临床试验监查工作。妥善进行研究中心的文件、研究产品、财务管理。 3) Conduct research in accordance with the protocol and applicable regulations: manage and review the work of the CRC; and filing the documentation in a timely manner; report quality issues identified to the responsible PM and/or line manager; work with the department to complete project audits and rectify any findings in a timely manner. Ensure the authenticity and compliance of the work of the research center.按照方案和适用的法规进行研究：管理、审核 CRC 的工作内容；并及时完成文件归档工作；将管理中心时发现的质量问题汇报给负责的 PM 和/或直线经理；配合部门完成项目的稽查工作，及时整改存在的问题。确保研究中心工作的真实性、合规性。 4) Responsible for the daily communication and relationship maintenance of the research center and ensure the completion of the clinical research ethics review and other processes of the research center. Provide protocol and study-related training to the center's investigators and communicate regularly about the requirements and resolution of various issues during the trial.负责研究中心的日常沟通和关系维护，保障研究中心临床研究伦理审查等流程的完成。对中心研究人员进行方案和研究相关的培训，并定期沟通试验进行中的要求和各类问题的解决情况。 5) Execute complex clinical trials as required.按要求实施复杂的临床试验。 6) Comply with company policies and rules, implement company policies, regulations and standard operating procedures.遵守公司各项规章制度，执行公司政策，实施公司的相关规范及标准操作流程。 7) Performs other duties as required. 视需要，执行其他职责。 【Required Qualifications (knowledge, skills and abilities) 】资格要求 (知识、技能和能力): 1) Good communication skills. 具有良好的沟通能力。 2) Strong sense of responsibility, work enthusiasm, meticulous, organized, patient, have a certain team consciousness, respect and execute the arrangement of superior, self-discipline, strong principle. 责任心强，具有工作热情，工作细致、条理性强、有耐心，有一定的团队意识，尊重和执行上级安排，自律性强，原则性强； 3) Familiar with IVD or/and MD clinical trial related laws and regulations. 熟悉 IVD 或/和医疗器械临床相关法律、法规。 【Required Education and Experience 】教育和经验要求： 1) Bachelor's degree or above in medicine, pharmacy, clinical, biology or related major or university degree with an equivalent amount of experience can be substitute as appropriate 医学、药学、临床、生物等相关专业，本科及以上文化程度或者具有同等经验的大学本科学历可以酌情替代。 2) At least 1 year relevant experience in clinical trials 1 年及以上临床试验项目相关工作经验 3) Previous experience in the full clinical research process and the ability to manage complex and challenging research centers.有过临床研究全流程经验，能够管理流程复杂、具有挑战性的研究中心。