FSP CTC(Shanghai)
On-siteShanghai, Shanghai, China
Job Summary
Coordinate site start-up and maintenance by collecting investigator documents and ensuring EC/IRB/Third body/Regulatory Authority applications meet timelines and specifications. Compile routine submissions to authorities, review final documents, and liaise with internal/external vendors to generate compliant materials. Serve as local expert and knowledge resource to mentor colleagues, while proactively resolving informed consent issues and escalating study risks to Submission Leads. Track contract milestones, customize patient consent forms, and manage CTIS uploads for EU trials to ensure audit readiness. Maintain awareness of current regulatory standards and ICH/GCP guidelines across assigned countries.
Required Qualifications
- University/College degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution (e.g., nursing certification, medical or laboratory technology)
- 2 years' work experience in clinical research
- strong working knowledge of the ICH guidelines and RA, IRB/IEC regulations
- Minimum of 2 years of experience in clinical development or start-up/ regulatory process
- Working knowledge of ICH, RA, IRB/IEC, and other applicable regulations/guidelines
- familiarity with investigator start-up documents and contract/budgets negotiation process
- previous interaction with operational project teams and investigative sites
- Demonstrated understanding of research protocol requirements
- proven ability to communicate them/educate others about them
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