Start-up Associate
Fortrea · Karnātaka, India
Clinical OperationsFull timeCompany career page
RoleLantern re-checked this role's application link recently and it was active — the employer has not confirmed it directly.
Role summary
Start-up Associate role supporting clinical trial site initiation and maintenance activities. Responsible for collecting regulatory documents, preparing submissions to ethics committees and authorities, and ensuring compliance with timelines and quality standards.
What they're looking for
- University or college degree in life sciences, or equivalent allied health certification
- 0–2+ years of relevant experience in clinical operations or regulatory affairs
- Working knowledge of ICH guidelines, regulatory affairs, and IRB/IEC processes
- Basic understanding of clinical trial processes and procedures
- Ability to manage documentation and track regulatory submissions
What you'll be doing
- Serve as primary contact with investigative sites for study startup and maintenance activities
- Collect, review, compile, and submit regulatory documents to ethics committees and authorities
- Ensure site activation and ongoing compliance with ICH/GCP standards and client expectations
- Track and update study documentation, personnel changes, and amendments in tracking systems
- Identify and escalate risks to project deliverables and timelines to senior staff
Privacy & handoff
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