职位描述
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职位标签:
??临床研究
职位职能:
??临床研究员??
职位描述:
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.
职位：临床研究员
工作地点： 北京
主要职责和工作目标
1. 负责梅里埃当地产品的注册及与中国当地注册部门（国家食品药品监督管理局和上海市食品药品监督管理局）的联系工作。
2. 负责安排临床实验，协调临床医院与实验医院的合作，编写Protocal，并负责临床实验过程中的相关事宜。
3. 根据国家食品药品监督管理局的要求，协调注册卷宗的准备工作（翻译、公证、立法）。催促、推动和协调注册中的各环节的工作，确保每个环节工作在国家食品药品监督管理局规定的标准时限内完成，不存在延迟现象。
4. 负责QC检测，试剂检测/仪器订购工作，防止因个人疏忽导致试剂过期现象，并获取最终的测试报告。
5. 负责文件整理工作，并与质量管理部门协调质量管理体系审核工作。
6. 负责新产品的注册、及老产品的二次注册和变更登记工作，直至其获得产品许可证。
具体知识和经验要求
工作经验和个人能力：
1. 良好的沟通能力和学习能力。
2. 良好的团队合作意识。
3. 高度的责任意识和良好的工作态度。
教育和知识要求：
1. 本科以上学历，拥有相关专业生物学或医学及相关专业者优先。
2. 良好的英文读写能力。
3. 拥有医疗注册和临床试验工作经验，IVD行业优先。
