上海晶抗生物工程有限公司
临床监查员CRA
Skills
2 months ago
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Important information
Contract type:
Permanent
Location:
Shanghai, China
Work mode:
Onsite
Published on:
7 September 2026
What they need
该职位来源于猎聘 岗位职责： 1.负责肿瘤领域临床试验全周期监查工作，确保符合ICH-GCP及国家药品监督管理局相关法规要求 2.独立管理研究中心的全流程工作，包括但不限于中心筛选、启动、定期监查及关闭访视 3.执行每月现场监查访视，确保临床试验数据质量、进度及合规性符合方案要求 4.建立完善的不良事件监测机制，确保重大不良事件（SAE）100%按时限要求完成上报 任职要求： 1.临床医学、药学或相关专业本科及以上学历，具有1-3年实体瘤项目临床监查员（CRA）工作经验 2.精通实体瘤疗效评价标准（RECIST 1.1），至少完整参与过2个I-II期肿瘤临床试验项目 3.具备优秀的项目管理能力，能够适应50%以上的出差频率，熟练处理多中心临床研究协调工作 4.持有有效的GCP培训证书，熟悉国家药品监督管理局（CDE）最新发布的肿瘤临床试验技术指导原则
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