工作职责: 1 Responsible for managing and archiving of clinical trial documents in collaboration with CRA and project leader in accordance with departmental SOP, including but not limited in collecting, uploading and maintenance. 遵守部门的SOP，负责临床试验中文件的管理，包括但不限于临床试验文件的收集、整理、上传、审核、归档等。 2 Support contracts and other documents process: both online and offline. 支持项目合同以及各类文件的签字、盖章流程：包括线上及线下流程。 3 Support GCP office and EC dossiers preparation: including printing, stamping and expressing. 协助项目组准备、制作立项及伦理文件夹：包括打印、盖章、邮寄等。 4 Support study teams develop and coordinate to manage the study budget, to ensure study payments are paid on time and the invoices are collected meeting financial requirements. 协助项目组管理项目费用，保证所有费用及时支付，发票按时回收并提交财务。 5 Supports electronic Trial Master Files (eTMF) QC as needed. 按照项目组的要求，对项目组上传至eTMF的文件进行核对。 6 Support the application of various system accounts and the management. 协助项目组申请及维护系统账号。 7 Support study team organizing internal meetings; provides enough logistic supports for investigator meetings and inspections. 协助项目组组织各种内部会议；支持外部活动，如研究者会及项目核查等。 8 According to the project requirements, complete the designated administrative work during the project, and provide support to team members in the execution of clinical trials. 根据项目的需要，完成行政类工作的支持。 9 Update and maintain internal databases, study related systems and study plans with study specific information. 整理项目的数据及信息，协助更新及维护内部数据库。 10 Support meetings/events or complete other tasks assigned by department head, line manager. 支持部门的会议/活动，完成直线经理或部门负责人安排的其他工作。 任职资格: Bachelor degree or above, major is not limited, clinical pharmacy, nursing or related major is preferred. 本科及以上学历，专业不限，临床医学、药学、护理学或相关专业优先。
At least 1.5 year of CTA experience; experience in Biotech or sponsor is preferred. 1.5年以上CTA相关工作经验，有创新型生物医药公司或申办方工作经验优先。
85 Familiar with Chinese Good Clinical Practice (GCP) and ICH-GCP and related regulations. 85 熟悉GCP及相关法规。 85 Computer skill including proficiency in use of Microsoft word, Excel, etc. 85 熟练掌握各类办公软件。 85 Strong sense of responsibility and communication skills, be able to arrange and handle multiple-tasks, good team spirit and pressure resistance ability. 85 有责任心，沟通能力强，能够合理安排及处理多项目工作，有良好的团队精神及抗压能力。
