- 招聘人数:1 人
- 到岗时间:不限
- 年龄要求:35周岁以上
- 婚况要求:已婚
1. Monitor clinical trials (including site initiation, monitoring, closure, data collection, etc.)
to assure that the trials are conducted in compliance with the GCP guidelines, study protocols, SOPs local regulations
负责临床试验的监查工作(包括site的启动、监查、中心关闭、数据收集等),确保试验严格遵循GCP原则,遵照临床试验方案、SOP和临床法规进行实施;
2. Communicate with the clinical research staff to ensure that the study is conducted in accordance with the protocol
SOPs 负责严格按照公司SOP和临床试验计划进行监查,及时发现、反馈问题给相关人员,以保证项目各方面满足临床试验要求;
3. Assist PI to recruit study subjects, dispense study drugs, data collection literature searching Count, retrieve
destroy study drugs at the end of the study 协助研究者招募受试者、药物发放、记录保存和文献查阅,试验结束后按程序清点、回收、销毁试验用药;
4. Assist clinical managers to convene the protocol discussion meetings, site initiation
meetings, interim meetings blinded data review meeting etc. 协助临床经理召开方案讨论会、启动会、中期会、盲态审核会议、总结会等,参与会议筹备;
5. Assist to prepare the related documents (protocol, source documents, CRF, informed consent) Collect data forms
after the completion of the study 协助临床试验用文档(试验方案、研究病历、CRF、知情同意书)的印刷,以及项目结束后的相关资料、表格的回收、归档工作;
6. Assist to trace the clinical trial data, check, answer queries other related work 协助临床试验数据的溯源、核对、答疑等相关工作;
7. Assist the researchers to report adverse events to the sponsors coordinate the
management of adverse events during the clinical trial 协助研究者向申办者报告试验数据及结果,负责临床研究过程中出现不良事件的协调处理
职位要求:
Requirments
1. Major in Medicine, Pharmacy or related discipline 医学、药学相关专业,专科以上学历;
2. At least two years of clinical monitoring experience 具有两年以上临床监查工作经历;
3. Familiar with GCP guidelines, willing to travel 熟悉 GCP 管理规范,能适应出差;
4. Good communication coordination skills 具备良好的沟通、协调能力;