高级临床监查员/scra(j10009) - Shanghai, Shanghai

仅限注册会员 Shanghai, Shanghai, 中国

3周前

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该职位来源于猎聘 职责描述: 1. 全流程质量管理: 独立负责肿瘤临床试验全流程监查,严格遵循GCP、试验方案及公司SOP;针对发现的方案违背(PD)及质量问题,能深入分析根本原因,协助研究中心制定并执行纠正预防措施(CAPA),确保持续合规。 2. 中心管理与推动: 主导参与试验中心筛选、启动与培训;不仅限于维护关系,需主动识别中心受试者招募瓶颈,协助研究者制定有效的招募策略,确保入组目标按时达成。 3. 安全性与数据监查: 执行现场/远程监查计划,核查入组、随访及数据一致性;重点关注肿瘤项目的安全性数据(SAE/AESI)的及时报告与处理,以及肿瘤疗 ...
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