Start-up Specialist
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Job Description
Study start-up specialist managing U.S. clinical trial documents, regulatory submissions, and site activation for Fortrea. Coordinating investigators, authorities, vendors, contracts, and compliance timelines.
Responsibilities:
- Serve as primary contact with investigative sites during study start-up and maintenance
- Collect, organize, quality-review, format, compile, and file investigator and essential study documents
- Coordinate EC/IRB/Third body/Regulatory Authority applications and submissions within agreed timelines
- Prepare country application forms, cover letters, and routine submissions such as INDs/CTAs
- Liaise with regulatory authorities, internal teams, external vendors, and investigative sites
- Review final submission documents and ensure compliance with regulations, ICH/GCP, SOPs, quality standards, budgets, and client expectations
- Track start-up, maintenance, site activation, contract, and budget activities and milestones
- Identify, prevent, and escalate study issues and risks to deliverables
- Maintain systems and documentation in an audit-ready state
- Participate in team and project meetings
- Assist with site activation strategy, projections, and timelines
- Review and customize country- and site-specific informed consent forms
- Support negotiation and tracking of site contracts and budgets when applicable
- Mentor and train new hires and less-experienced colleagues when suitable
- Perform other duties as assigned
Requirements:
- Residing in the United States
- University/College degree in a relevant field (life science preferred), or certification in a related allied health profession from an appropriate accredited institution
- Relevant and equivalent experience may be considered in lieu of educational requirements
- Alternatively, High School Diploma or equivalent plus at least 2 years of clinical research experience
- Minimum 2 years of experience in clinical development or start-up/regulatory processes
- Strong working knowledge of ICH guidelines and RA, IRB/IEC, and other applicable regulations/guidelines
- Familiarity with investigator start-up documents and contract/budget negotiation processes
- Previous interaction with operational project teams and investigative sites
- Demonstrated understanding of research protocol requirements and ability to communicate/educate others about them
- Ability to work in a fast-paced, constantly changing, technology-based environment
- Ability to sit for extended periods and operate a vehicle safely
- Ability to perform repetitive hand movements and occasional crouching, stooping, bending, and twisting
- Ability to use various computer software
- Ability to lift/carry 15–20 lbs
- Regular and consistent attendance
- Varied hours may be required
Benefits:
- Frequent travel to clients/site locations with occasional domestic and international travel
- Ongoing application acceptance
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