職位描述
?
職位標簽:
??臨床研究
職位職能:
??臨床研究員??
職位描述:
JOB TITLE: Clinical Research Associate
Location: Beijing
PRIMARY PURPOSE AND OVERALL OBJECTIVE OF THE JOB
1. Responsible for arranging the clinical trials, coordinating the selection of clinical hospital; preparation of EC documents; coordinating the establishment of clinical protocol; contacting the related person for clinical trials; ordering the reagents of clinical trials in time; No expired reagent because of personal negligence.
2. Responsible for coordinating the registration dossiers preparation (translating, notarizing, legislating) according to the requirements of SFDA. Urging, pushing and coordinating in each step of the registration, make sure that the steps would be finished within SFDA’s standard time limit, no delay in each steps.
3. Responsible for the QC testing, testing reagent/instrument ordering. No expired reagent because of personal negligence. Responsible for getting the final test report.
4. Responsible for document preparation and coordinate the QMS audit with QMS department.
5. Responsible for the local products new, renew, modify registration, following all the process of it until get the product license.
6. Complete main task in a timely manner.
KNOWLEDGE AND EXPERIENCE REQUIRED FOR THE JOB
Experience & Personality:
1. Good communication skills and learning ability.
2. Good sense of teamwork.
3. Strong sense of responsibility and good work attitude.
Education & Knowledge:
1. Bachelor degree or above in biology, clinical medicine or related subject priorities.
2. Good English skill including read and write.
3. Registration and clinical trial work experience in healthcare industry, IVD is preferred.
職位：臨床研究員
工作地點： 北京
主要職責和工作目標
1. 負責梅里埃當地產品的注冊及與中國當地注冊部門（國家食品藥品監督管理局和上海市食品藥品監督管理局）的聯系工作。
2. 負責安排臨床實驗，協調臨床醫院與實驗醫院的合作，編寫Protocal，并負責臨床實驗過程中的相關事宜。
3. 根據國家食品藥品監督管理局的要求，協調注冊卷宗的準備工作（翻譯、公證、立法）。催促、推動和協調注冊中的各環節的工作，確保每個環節工作在國家食品藥品監督管理局規定的標準時限內完成，不存在延遲現象。
4. 負責QC檢測，試劑檢測/儀器訂購工作，防止因個人疏忽導致試劑過期現象，并獲取最終的測試報告。
5. 負責文件整理工作，并與質量管理部門協調質量管理體系審核工作。
6. 負責新產品的注冊、及老產品的二次注冊和變更登記工作，直至其獲得產品許可證。
具體知識和經驗要求
工作經驗和個人能力：
1. 良好的溝通能力和學習能力。
2. 良好的團隊合作意識。
3. 高度的責任意識和良好的工作態度。
教育和知識要求：
1. 本科以上學歷，擁有相關專業生物學或醫學及相關專業者優先。
2. 良好的英文讀寫能力。
3. 擁有醫療注冊和臨床試驗工作經驗，IVD行業優先。
