Major Responsibilities主要职责 参与/提名新的临床试验研究中心，评估研究中心临床试验能力并提出建议Participate /nominate new sites for clinical trials; perform evaluation of site capability and make recommendation for inclusion in clinical trial. 作为试验协调人与内外部客户进行沟通，增加客户价值Assume ambassadorial role to facilitate communication between sites and Key Novartis line functions to increase value proposition to investigators. 资料备案以及临床研究中心单据收集Facilitate preparation and collection of site level documents. 临床试验研究中心的启动及培训Execute site initiation and training activities. 执行研究中心的数据监查Perform monitoring visits according to monitoring plan. 管理研究中心的药品供应Manage site drug supply management. 更新所负责研究中心信息系统（如Clin Admin, EDC ）Resolve site level update of technical systems (Clin Admin, EDC). 保证各中心项目按计划进行（如启动，招募，关闭等等）Ensure site activities in line with milestones (i.e. startup, recruitment, closeout, etc). 必要时制订应急招募受试者预案Manage recruitment implementing appropriate contingency plans as needed. 保证试验按照GCP – ICH及诺华的标准操作流程进行。
（知情同意程序，原始数据校对，不良事件和严重不良事件报告，研究者通告报告，方案执行以及药物计数等）Assure continual, and Novartis SOP compliance (Informed consent process, Source data verification, AE and SAE reporting, IN, protocol, drug accountability etc.) 通过纠正措施和培训解决试验偏差Resolve deviations to standard by remedial action and training. 撰写研究监查报告Author study monitoring reports. 解决研究中心的数据质疑（Perform data query resolution process (both at Site and with Data Management). 关闭实验研究中心Execute site closeout activities. Ideal Background 背景 Education:教育背景: 医药类专业本科或以上　 Languages英语: 说写流利 Experience:工作经验 1年以上 Competency Profile 能力要求 基本的医学业务知识Basic medical and business knowledge; 了解临床实验的设计和实施Understands and can apply knowledge of clinical trial designs to trial execution; 了解临床实验研究的国际国内准则（GCP/ICH ，FDA, EMEA） Knowl-edge and experience in international standards (GCP/ICH), international (FDA, EMEA) and local regulations; 优秀的沟通技巧和时间管理能力，熟悉计算机系统操作Expertise in communication, managing multiple priorities and computer literacy.

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