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临床监查员
2023.11.11

工作职责:
1、配合临床项目经理和监查经理实施国内临床项目:
(1)根据产品临床计划,确定项目经理实施临床所需资料,关键时间点和相应负责人。
(2)实施临床计划,对临床试验流程各个节点工作进行把控和实施,按期启动临床中心、完成入组、随访、按期关闭中心。
2、负责临床试验中心机构、伦理、科室的日常沟通和维护,确保试验顺利开展。
3、供应商的管理和督促:确认CRO和CRC按合同开展相关工作。
4、完善国内临床试验工作流程文件。
5、所负责临床单位试验样品的管理、核对、出入库。
6、突发事件处理及上级交办的其他工作。

 

岗位要求:
1、本科及以上,临床医学、护理学、药学或生物医学专业等优先。
2、相关专业年限:3年以上;具有医疗器械、医药CRA工作经验者优先;具有医学相关专业工作经验者优先。
3、英语水平良好,有较强的读写能力,6级以上优先;
善于与他人沟通,有良好的服务意识以及较强的应变能力。
4、有较强的团队合作精神;有责任心、积极进取、谨慎细致、条理性强;熟练使用各种办公软件及设备。

Please submit your resume to:xtzhaopin@microport.com
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