工作地点：上海、南京、武汉、广州、成都、长沙、北京
Responsibilities:
1. Supports regulatory inspections and/or audits as required. 支持监管检查和/或审计，按需提供协助。
2. Interfaces with vendors as required。 按需与供应商进行对接。
3. Procures, maintains, and ships study documents, supplies, and materials in compliance with the Company Standard Operating Procedures (SOPs) and study-specific processes. 依据公司标准操作程序（SOPs）和特定研究流程，采购、维护并运输研究文件、用品和材料。
4. Maintains study servers and portals where applicable. 在适用情况下维护研究服务器和门户网站。
5. Tracks documents and study status in applicable tracking systems. 在适用的跟踪系统中跟踪文件和研究状态。
6. Reports document collection and tracking issues to functional lead and/or study team on a regular basis. 定期向职能主管和/或研究团队报告文件收集和跟踪问题。
7. Identifies, manages, escalates where appropriate, and resolves site issues effectively. 有效识别、管理、在适当情况下升级并解决现场问题。
8. Assists with ad hoc issue resolution as directed and delegated. 按指示和委派协助解决临时问题。
9. Communicates functional area study status and provides associated reports to the study team as appropriate. 在适当情况下向研究团队通报职能领域研究状态并提供相关报告。
10. Submits documents and/or files directly within TMF, may conduct document review and/or support with document query resolution. 直接在试验主文件（TMF）中提交文件和/或文件夹，可能进行文件审核和/或支持解决文件查询问题。
11. Performs regular support of site level document collection via Clinical Research Associate (CRA) and/or directly from site where requested.
12. 按要求通过临床研究协调员（CRA）和/或直接从现场定期支持现场级文件收集。
13. Assists ongoing completeness review of assigned content within TMF. 协助对分配的TMF内容进行持续完整性审查。
14. Conducts designated final site level TMF review and provisions partial final document collection expectations by CRA at Close Out Visit .进行指定的最终现场级TMF审查，并在关闭访视时提供CRA部分最终文件收集预期。
15. Supports study team with functionality and use of TMF in accordance with study-specific TMF Plan, the Company SOPs and study-specific processes. 根据特定研究的TMF计划、公司SOPs和特定研究流程，支持研究团队使用TMF功能。
Job Requirements:
1. Bachelor's degree or above in Clinical Medicine, Pharmacy, Nursing or related fields. CET-6 or above, with good English communication skills.临床医学、药学、护理学或相关领域本科及以上学位。英语六级及以上，具备良好的英语沟通能力。
2. Proactive, responsible, and detail-oriented.积极主动、责任心强、注重细节。
3. Strong communication skills and logical thinking. 具备较强的沟通能力和逻辑思维能力。
4. High execution ability and stress tolerance.执行力高，抗压能力强。
5. Internship experience in biopharma companies is a plus. 有生物医药公司实习经验者优先。