Start-up Specialist, Phase I
Fortrea · Durham, NC
Clinical OperationsFull timeCompany career page
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Role summary
Fortrea seeks a Study Start-Up Specialist with 2+ years of clinical research experience to manage site activation and regulatory submissions. The role involves coordinating with investigative sites, preparing IRB/IEC submissions, and ensuring compliance with regulatory standards and timelines.
What they're looking for
- 2+ years clinical research or start-up/regulatory process experience
- University degree in life science or equivalent certification (nursing, medical, lab technology)
- Strong knowledge of ICH guidelines, regulatory affairs, and IRB/IEC regulations
- Familiarity with investigator start-up documents and contract negotiation processes
- Understanding of research protocol requirements and ability to educate others
- High school diploma with 2+ years clinical research experience acceptable
What you'll be doing
- Coordinate collection and organization of documents required by EC/IRB/regulatory authorities
- Compile and prepare submissions to IRBs, IECs, and regulatory authorities for approval
- Serve as primary contact with investigative sites during start-up and maintenance phases
- Review and customize informed consent forms for local compliance requirements
- Monitor start-up activities to ensure alignment with timelines, budgets, and regulatory compliance
Privacy & handoff
This role links to Fortrea's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.