上海凯莱英生物技术有限公司
临床监查员-北京
Skills
2 months ago
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Important information
Contract type:
Permanent
Location:
Beijing, China
Work mode:
Onsite
Published on:
16 August 2026
What they need
该职位来源于猎聘 岗位职责: 1. 通过规范的监查过程,按时完成临床试验监查工作,确保所有试验严格按照试验方案、SOP和GCP的要求进行; 2. 负责临床试验中心的协调、监查与质量控制、进度督促、报告、文件管理等; 3. 与研究者沟通并共同协商解决出现的问题,协调处理研究项目负责人、临床医生、辅助科室、临床基地、患者等各方关系; 4. 对所负责的研究中心进行临床试验相关的培训; 5. 应对监查、稽查;为申办者准备、提供所要求的各种文件; 6. 与其他职能部门共同合作; 7. 完成直线经理和/或项目经理(PM)分配的其他工作。 任职资格 1.医学、药学相关专业本科及以上学历; 2.了解临床试验管理规范(GCP)和临床工作相关法规者优先; 3.1-2年CRA经验,有肿瘤项目经验(优先考虑乳腺癌、血液瘤、实体瘤、肿瘤I期),既往企业经验优先考虑CRO经验; 4.能适应经常出差。
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