山东吉威医疗制品有限公司
临床监查员(CRA)
Skills
2 months ago
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Important information
Contract type:
Permanent
Location:
Kunming, Yunnan, China
Work mode:
Onsite
Published on:
2 September 2026
What they need
该职位来源于猎聘 工作职责: 1、负责临床试验的具体实施和监查工作,及全过程的质量控制,确保项目按照国家GCP要求、试验方案和公司要求进行; 2、负责整理和完善所有试验文档及资料,发放、回收及销毁试验品,保证保管妥当、过程合规; 3、负责监查并报告试验进度和质量,及时发现问题、分析问题、提出解决方案并实施; 4、负责对试验研究过程中的不良事件进行跟踪,保障受试者权益及公司利益; 5、负责定期归纳并提交监查报告,填写相关报告及试验记录,确保数据真实、准确、完整; 6、负责定期与负责分中心PI和SI沟通,培养并保持良好的关系。 任职资格: 1、2年以上医疗器械产品注册或临床相关工作经验; 2、熟悉临床试验流程,熟悉GCP要求,了解专业英语; 3、熟悉办公软件的使用,具备良好的沟通能力,具有GCP证书者优先; 4、本科及以上学历,医药、临床、卫生及相关专业; 5、具备韧性、责任心、耐心; 6、适应出差。
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