IVD临床监查员CRA

5 months ago

Huangpu Qu, China Osmunda Medical Technology Service Group Full time

职位描述：

1、根据试验方案、合同规定的工作范围、SOP和GCP的要求进行临床试验的机构筛选、启动、监查和结题；
2、同时负责多个试验方案、研究中心和治疗领域的研究中心监查工作；
3、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，以处理项目进行中的问题；
4、评估研究中心工作的质量和完整性，确定研究中心是否是按照方案和适用的法规进行研究，将质量问题及时汇报给负责项目的PM和/或直线经理；
5、通过追踪注册申报和批复、招募和入选、病例报告表（CRF）完成和递交以及数据疑问产生和解决的情况，管理所负责研究中心的进展；
6、创建和维护与研究中心管理、监查访视的发现以及行动计划相关的文件，递交访视报告和其他所需研究文件；
7、协助相应研究中心的研究财务管理；
8、完成直线管理人员和/或项目经理（PM）分配的其他工作。

任职资格：

1、临床医学、基础医学、预防医学、检验医学等医学相关专业或药学、生物技术等相关专业本科及以上学历；
2、半年及以上的IVD临床项目参与经验；
3、良好的中文表达能力、CET 4或同等英语水平；
4、有医院工作经验或同岗位工作经验，优先考虑；
5、对国内IVD临床试验的相关法规有一定了解；
6、了解临床试验的项目流程。

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