Start-up Associate
On-siteMexico City, Mexico City, Mexico
Job Summary
Conduct primary contact with investigative sites for study maintenance and startup activities, collecting required investigator and regulatory documents to ensure timely EC/IRB/Third body submissions. Assist senior staff in compiling, preparing, and submitting approval documents to regulatory authorities while liaising with internal and external vendors. Perform quality reviews of final submission documents, organize communication regarding outcomes, and escalate study issues appropriately. Manage country-specific tasks including document formatting, compilation for site activation, and maintaining systems for audit readiness. Adapt informed consent forms to local requirements and support contract negotiations under supervision.
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)
- Minimum 0 – 2 + years of experience, or an equivalent combination of education and experience to successfully perform the key responsibilities of the job
- Working knowledge of ICH, RA, IRB/IEC, and other applicable regulations/guidelines
- Demonstrated basic understanding of the clinical trial process
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