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HE
临床监查员CRAⅠ~Ⅲ(杭州)
hengrui · 杭州市, 浙江, 中国
About The Role
主要负责上市前创新药化药项目(主要二三期大临床),肿瘤药+非肿瘤药 工作职责: 1.主要负责监查Ⅱ、Ⅲ期临床试验全过程的实施情况; 2.根据试验方案和GCP的要求进行研究中心筛选、启动、监查和关闭访视; 3.负责项目的进度与质量控制,保证试验数据的及时、规范和准确录入,确保资料数据的真实性、可靠性和完整性; 4.对所负责的研究中心进行方案和研究相关的培训,与研究中心进行定期沟通以管理项目进行中的要求和问题。协助研究中心解决试验过程中可能出现的问题; 5.负责项目各阶段进展的沟通协调与汇报; 6.负责CRC的培训指导与管理。 岗位要求: 1. 本科及以上学历,医药类相关专业; 2.具有1年以上药品临床监查或至少2年及以上药品CRC相关工作经验; 3.熟悉GCP、ICH-GCP以及临床研究相关规定、法律、法规; 4.具备良好的沟通能力、执行力、领悟力以及人际交往能力; 5.能独立协调处理试验环节所涉及的各职能,保障试验项目顺利开展。
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