Start-up Specialist
On-siteMexico City, Mexico City, Mexico
Job Summary
Coordinate site start-up and maintenance activities by collecting investigator documents and ensuring EC/IRB/Third body/Regulatory Authority applications meet regulatory timelines and specifications. Compile routine submissions for IRB/IEC/Third body/Regulatory Authorities, including INDs/CTAs, and liaise with vendors and internal teams to generate compliant documentation. Review final submission documents, customize patient informed consent forms for local compliance, and proactively resolve site-specific difficulties. Serve as a knowledge resource to mentor new hires and less-experienced colleagues while tracking contract milestones and escalating risks to Submission Leads. Assist in CTIS uploads for centralized EU roles and ensure systems remain audit-ready.
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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