Key Responsibilities Operational Conduct of Clinical Studies/临床试验运营执行 一. Pre-study Activities/临床研究前期工作 1. Assist Study Manager and sponsor representatives to sites and investigators identification and selection, including site feasibilities. 协助临床研究经理和申办方完成研究中心和研究者的可行性分析报告。 2. Assist Study Manager and sponsor representatives with preparation of study budget. 协助临床研究经理和申办方准备项目预算。 3. Prepare documentation for Ethics Committee submission and HGRAC application. 为伦理委员会和人类遗传资源管的项目申请准备资料。 4. Coordinate receipt and distribution of clinical trial supplies. 协调临床试验供给物资的接收和发放。 5. Ensure required documents ready for site initiation process. 确保收集相关的用于研究中心启动所需要文件。 6. Liaise with investigators and site staff regularly to ensure effective initiation of studies. 与研究者和研究中心人员保持日常的密切联系以确保项目的有效启动。 7. Develop appropriate monitoring tools。开发适合的监查工具。 8. Support Sponsor& Study Manager to organize investigator meetings within budget. 协助申办方和临床研究经理组织研究者会议并控制预算。 二. Site Monitoring Activities/研究中心的监查 1. Prepare and conduct initiation visits according to Study Monitoring Plan. 按照研究监查计划准备并实施研究启动访视。 2. Oversee assigned clinical trials to ensure compliance with ICH-GCP guidance, local regulation, and the SOPs of Sponsor and /or dMed. 管理所分配的临床研究以确保遵从药物临床试验质量管理规范（ICH-GCP）、国家法规监管要求以及法规监管要求以及 申办方和/或缔脉的标准操作规程（SOPs）。 3. Monitor and document the progress of assigned clinical studies through regular visits and telephone contact with site personnel following with Study Monitoring Plan. 按照研究监查计划，对计划，对研究中心人员进行定期访视和电话联系 ，对所分配的临床研究进行监查并 记录项目的进展。 3. Liaise with Study Manager regularly on study status through monitoring reports and meetings. 通过监查报告和会议等形式定期与临床研究经理汇报进展。 4. Liaise with other CRAs on study progress to maintain consistency if working on the same study. 与其他临床研究专员 一起协作交流研究进展确保同一项目的一致性。 5. Document all study related communications in a timely manner. 及时记录项目相关的沟通意见和问题。 6. Perform Source Data Verification to ensure accurate data is recorded in a timely manner. 及时对原始文档进行确认以保证数据记录的准性。 7. Ensure all Serious Adverse Events are reported timely and followed up according to regulatory requirements, Sponsor and/or dMed SOPs. 依照法规要求，申办方和/或缔脉标准操作流程（ SOPs），确保所有严重不良事件及时汇报，并进行后续随访。 8. Maintain drug accountability of all clinical supplies and arrange for destruction as per specified clinical study. 维护并清点临床研究的供给物资和药，并根据项目的要求安排销毁。 9. Ensure study documentation for each clinical trial is complete and returned to Sponsor or dMed in accordance with set schedules. 确保每一个临床研究的文挡完整性并按照所设定时限在申办方或者缔脉归档。 10. Ensure documentation is maintained according to Sponsor or dMed SOPs. 确保遵从申办方或者缔脉的标准操作规程进行文档管理。 11. Track site payments to ensure payments are on time and within budget. 管理研究中心项目应付款项以保证付款及时性以预算控制。 12. Coordinate the resolution of data queries within a required timeframe. 协调数据疑问表在要求的时限内解决。 13. Perform or support site self-assessment if required by site/sponsor. 根据研究中心 /申办方的要求进行或支持研究中心自查。 14. Perform study closeout visits at the completion of database lock. 数据库锁定完成后进行项目的结束访视。 15. Support & coordinate with site to achieve site master files to ensure the competence and also to meet the requirements of site GCP office. 支持和协助研究中心进行文件夹的归档，确保文件是完整的，并满足中心临床研究管理机构的要求。 16. Support site audit or inspection if any and ensure the CAPA completion with the required timeframe. 协助研究中心的稽查和核查，确保修正预防性措施在规定时限内完成。 Reporting/报告 1. Accurate completion of Monitoring visit reports with the required timeframe and ensure all issues are correctly identified and categorized. 按规定时间准确完成研究监查访视报告 ，确保准确的记录和分类所有发现问题。 2. Ensure regular updating of trial management systems. 确保定期更新研究管理系统。 3. Prepare study progress reports for Study Manager /Sponsor by specified dates, which is copied to manager of site management. 按时准备研究进度报告向临床研究经理或申办方汇报并通知到直接主管。 4. Ensure all significant quality issues identified in the site are reported per Sponsor/dMed SOP requirement. 确保按照申办方/缔脉的标准操作规程（ SOP）报告所有在研究中心发现的严重质量问题。 Professional Experience & Education Requirement 1. Minimum Medical or pharmaceutical education background or other life science degrees (or equivalent); clinic practice is preferred. 医学或者医药教育背景生命科专业学位同等专业 ，有临床经验者优先。 2. Good working knowledge of GCP guidelines. 熟悉药物临床试验质量管理规范。 3. Proficiency in Basic Microsoft Word and Excel and familiarity with use of database. 精通基本的办公自动化软件和数据库使用。 4. Knowledge of drug development process. 具备药物开发过程的知识。 5. Customer orientation and service mindset. 客户至上和良好的服务意识。 6. Self-awareness and self-motivated. 良好的的自我认识意识和自我驱动能力。 7. Well-developed of communication (Chinese & English), presentation, and interpersonal skills. 良好的中英文沟通、演讲和人际沟通技巧。 8. Able to plan, organize and prioritize various types of work and projects efficiently 有一定的计划组织能力，并能够将各项工作按照重要性合理安排保证项目的效率。 9. Capability to identify issue and solve problems effectively and proactively 能够高效、主动地发现和解决问题。 10. Resilient to changing project requirement or business needs with proactive approach 面对不断变化的项目需求，能够主动灵活地处理。 11. Ability to travel as needed. 能够按需经常出差。 备注： ‘职位月薪’ 仅供参考，具体薪资和福利将根据候选人经验和能力综合评定。