上海招聘

职位描述：
岗位特色：
 
- 将CRA的site monitoring实践经验与项目管理更加有效结合，直接参与跨国多中心Clinical Study项目支持与管理
- 培养Global Clinical Study Project Management的国际视野与经验
- 拥有更多"不出差"的时间
- 跨国团队协同合作，更好的提供了多文化环境下学习和工作的机会
 
技能要求：
 
- 3年以上CRA行业经验，有Lead CRA or 项目管理经验者优先考虑。
- 良好的英语能力
- 良好的沟通能力
 
如果你有clinical site monitoring的经验，同时也希望获得临床项目管理方面的知识和经验积累，那就请不要犹豫，赶快联系我们吧。


Primary Function:
The Lead Clinical Analyst (LCA) partners with the Clinical Lead (CL) and local country Site Monitors in project execution. The LCA provides centralized support and contributes to site management for a variety of protocols, sites and therapeutic areas. LCA creates study specific operational plans, supports study start-up, manages resource requests, performs ongoing clinical risk assessment through data trending and analytics and proposes potential mitigating actions in a timely fashion, and manages Investigators payments. The LCA liaises with and mentors the Clinical Analyst Support (CAS) on trial.
Roles & Responsibilities:
Study Start-up
1. Support the CL to develop the Clinical Operations Plan (COP), and study-specific documents, which may include but are not limited to: The Monitoring Plan, SDV Plan, Study Reference Manual/Guidelines/Instruction, annotated Site visit report, annotated Recruitment Strategy Plan (RSP) and Site Recruitment Action Plan (SRAP), letter templates, scripts for remote monitoring visits and telephone contact report templates as applicable. The LCA also develops training material for SSV / SIV.
2. Request resources in QRPM that will included the Clinical Trial Assistant (CTA) and Clinical Analyst Support (CAS), Clinical research Associates (CRA), and team members as applicable
3. Manage system access for site management team.
4. Maintain all study specific trainings and assign to team members as applicable. Confirm training compliance of all team members prior to assigning study specific tasks.
5. Confirms that all Helplines/toll free numbers have been requested and activated as per scope by each operational lead as appropriate (e.g. Helpdesk lead (EDC), IVRS, Labs, and others, as applicable).
6. Review and approve Site Selection Visit reports (SSVR) as applicable, and follow up on action items in SSVR
7. Create and upload Subject Visit Template (SVT) for Investigators Payments
8. Play a key role developing the table of content of the Investigator Site Files and eTMF
Maintenance
9. Request monitor resources for site initiation and site monitoring visits. Review the QRPM Resource Management Dashboard and resolve any items that need attention (i.e., Resource assignment errors, Queried requests, and Inactive resources still assigned).
10. Manages system access for the site management team (CTA, CRA and CAS) and investigator site teams.
11. Develop and provide instructions and forms for IP inventory, accountability, reconciliation, relabeling, recall and destruction/return.
12. Ongoing tracking and support for management of regulatory approvals, ethics committee approval and Import license review. Closely works with local regulatory staff to manage ongoing regulatory and ethics submissions.
13. Support CL to conduct project specific trainings and maintain training attendance as applicable. Post all training materials on the project’s ELVIS/e-Training folder. Perform an ongoing training compliance check for project specific training for Quintiles team members.
14. Attend and deliver site management related training during the Investigators Meeting as required.
15. Generate and review weekly/monthly reports to manage Key site management deliverables.
16. Review on a daily basis any new Project Alerts on the Infosario Alert Dashboard and complete any actions that may be required.
17. Manage oversight for COP compliance in consultation with CL. LCA to confirm that CRA’s adhere to timelines for completion of SVRs and follow-up letters
18. Track and follow-up with CRA’s on non-recruiting sites and propose mitigation action. Follow appropriate escalation processes, including zero enrolment letter and site closure, as agreed per project. Support CL to revise project recruitment strategies as needed.
19. Support the CL to update Operational group plans and related documents throughout the study.
20. Work closely with the CRA, CTA, and CAS to ensure that the relevant study systems are updated.
21. Ensure eTMF compliance to filing plan by regular QC.
22. Review and approve investigator payment batch.
23. Review Site Visit Reports as applicable.
Study closeout
24. Coordinate close-out of all study sites and ensure systems are updated.
25. Coordinate Regulatory & IRB/EC country close-out activities (including end of trial notification).
26. Follow up with CRA’s to confirm that all IP has been reconciled and returned/destroyed as per project specifications.
27. Follow up with CRA’s to confirm that all study equipment provided to the sites have been returned as per project specifications, Clinical Trial Agreement, and customer contract as applicable.
28. Confirm that all sites have submitted final reports to their respective IRBs/ECs.
29. Identify / execute gradual release of CRA resources during close-out phase as needed.
30. Reconciliation of final site payments.
31. Ensure compliance to document archival plan
32. Any project-specific phone lines, Intercall or WebEx accounts should be closed.
33. Provide assistance as required in CSR preparation. 举报 分享

QuintilesIMS pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster.
 
If that is your passion, we have a place for you.