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廣州海博特醫藥科技有限公司

職位信息:

臨床監查員(上海)(2人) 【收藏】

薪  水: 面議 學歷要求: 本科 工作地點: 上海
有效期至: 2019-06-30 經驗要求: 無要求 發布日期: 2013-09-26

職位描述:

1、熟悉試驗藥物的相關知識,熟悉臨床試驗研究用資料的內容,熟悉臨床試驗SOP和GCP規范等相關法規。 2、按照申辦者的要求,確保各醫療中心能夠正確地實施臨床試驗方案和記錄臨床試驗數據。 3、在試驗前確認承擔試驗的醫療機構已具備完成試驗的適當條件。 4、核實整個試驗過程中試驗用藥品的保存、使用、儲存情況。 5、了解研究者在臨床試驗過程中對試驗方案的執行情況。 6、核實研究者和所有參加試驗的人員履行試驗方案和書面合同中規定的各自職責,確保所有臨床試驗產生數據的完整性、真實性、一致性、準確性。 7、核對病例報告表填寫情況、受試者試驗用藥品使用情況、藥品不良反應記錄情況等各方面情況。 8、核對病例報告表內容真實準確,完整無誤。 9、確定所有不良事件按照GCP法規、試驗方案、倫理委員會的要求,在規定的期限內報告了申辦者和藥監管理部門。 10、確定研究者是否按照GCP規范保存了必備文件。 11、確定臨床試驗發生的偏離了試驗方案、SOP、GCP和相關法規要求的情況,應及時與研究者進行溝通,并采取適當措施防止偏離再次發生。 12、每次訪視監查后,必須作書面報告遞送申辦者。 13、監查員應將監查結果及時的提供給申辦者及臨床試驗相關人員,申辦者要委派專人對監查員報告中所談及的問題進行審評和隨訪,并形成文件保存

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