1、Involves the quality oversight for assigned clinical studies (phase 1/2/3) in close collaboration with the clinical study team.
在与临床研究团队密切合作的情况下，参与临床研究（1/2/3期）的质量稽查工作。
2、Provides guidance to the clinical study team to ensure clinical studies are executed compliant to GCP, local regulatory requirements and Evive processes. 为临床研究团队提供支持，确保临床研究的开展符合GCP、当地法规要求和亿一的工作流程。
3、Involves the design of study risk management plans and coordinates the definition of appropriate risk responses.
参与制定研究项目风险管理方案及提供应对措施。
4、Monitor study / site / vendor for quality risks and proactively define appropriate risk reducing measures.
稽查项目研究/现场/供应商的质量风险，并主动提供降低风险的应对措施。
5、Involves the audit site selection process for study‐specific audit plans in collaboration with the study team and oversees the timely audit conduct, reporting, review, and closeout in accordance with Evive Processes.
与研究团队合作，参与筛选稽查中心及制定相应的稽查方案，并根据公司流程监督稽查工作的整体执行情况、报告、审查和收尾工作。
6、Participate in / lead GCP audits.
参与并负责GCP稽查工作。
7、Produces in close collaboration with clinical study team GCP quality metrics allowing real‐time quality monitoring and reporting; conducts trend analyses of GCP quality system metrics (e.g., audit observations, deviations, CAPAs, GCP QA activities) for management reporting.
与临床研究团队密切合作，制定GCP质量保准，进行实时质量监控，及时提交稽查报告，总结稽查问题；对GCP质量系统标准（例如，稽查观察、偏差、CAPAs、GCP QA活动）进行分析，以便进行报告管理。
8、Assist and participate the investigation of study quality events and the definition of necessary corrective and preventive measures.
协助和参与研究质量事件的调查，提供必要可行性的改进建议和预防措施。
9、Assists the inspection readiness activities.
负责相关稽查准备活动。
10、Other tasks arranged by the leader.
领导安排的其他任务。
工作经验
1、3-5 years’ and above work experience of clinical research audit, including at least one biological product clinical trial of phase II or III. 3-5年及以上临床研究稽查工作经验，包括至少拥有一个2期或3期生物制品临床试验经验。
*Once or more times experience of health authority (China domestic, NMPA and other countries national agencies such as FDA and EMA) on-site inspection. 一次或多次监管机构，如NMPA、FDA或者EMA的现场核查经验。
*Know clinical research related affairs work content and flow of each function. 熟知临床研究相关事务和每个职能的工作内容和流程。
*Experience and knowledge in clinical laws, regulations and guidelines. 具有临床法规和指南的经验及相关知识。
其他要求
1、Fluent oral and written English (CET-6 or other certificates). 流利的英语口语和书面表达能力（CET-6或其他证书）。
2、Have desire of keep learning, progression and self-discipline. 具有持续学习的热情并自律。
3、Good at cooperate with colleagues, other functions and suppliers. 具有与同事、其他部门和供应商进行良好沟通合作的能力。