CTA 临床试验助理

工作职责 （Responsibility）：
1. 支持特定项目团队建立TMF并确保所有的研究文件按照SOP进行归档，按照项目TMF管理计划进行文件的。
QC Assist to set up TMF folder and ensure TMF archiving with company SOP，and perform the QC according to project specific TMF management plan.
2. 支持项目团队的会议组织（临床试验相关的研究者会议，咨询会议等），帮助部门组织团队建设活动。
Assist the project meeting, IM, record the meeting and progress report etc, also support for the department TB.
3. 协助项目团队进行所需伦理递交文件的打印和准备。
Assist to contact with vendor for printing of EC documentation according to the scope of work and standard operating procedures .
4. 参与供应商的管理，包括组织供应商竟标，比价，合同签署及在整个研究期间的维护。
Assist with vendor management ,such as organize meeting of bidding, contract signing and contract m maintenance etc.
5. 研究中项目经理安排的其他相应的任务。
May perform assigned administrative tasks by the project managers.
6. 协助试验相关的文件翻译。
Assist to contact with vendor for related clinical docs translation.
7. 为部门新员工提供入职支持。
Provide supporting for new onboarding staff.
8. 为项目建立相关的系统如AIS, CTMS等。
To set up the system for specific project, for example, AIS, CTMS.




任职要求 (Qualification):
1. 生命科学领域本科及以上。
Bachelor degree and above in the science area.
2. 熟练掌握MS-office。
Computer skills including working knowledge of Microsoft Word, Excel and PowerPoint.
3. 英语和普通话流利（书面和口头）。
Good written and verbal communication skills including good command of English language.
4. 良好的沟通能力，时间管理以及组织能力。
Effective communication ,time management and organizational skills.