Start-up Specialist, Phase I

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.

Responsibilities

• 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

Requirements

• 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