Navigator

• Coordinate site-level activities throughout the clinical study start-up phase and potentially closeout activities
• Serve as the primary point of contact for investigative sites from feasibility and initial outreach through site activation and maintenance
• Ensure regulatory compliance, site management, site support and training, and collaboration among sponsor, CRO, and clinical site staff
• Identify and assess potential research sites
• Conduct initial site outreach, collect confidentiality agreements, and complete feasibility surveys
• Conduct remote pre-study visits and complete follow-up documentation
• Support customization and translation of informed consent forms and patient-facing materials
• Collect, track, and quality-review essential documents for site activation and ongoing regulatory compliance
• Participate in team meetings, implement site-level risk action plans, and escalate issues
• Support CRA teams with site initiation visit preparation and coordinate vendors, supplies, site access, and documents
• Submit to and liaise with IRB/IEC, third bodies, and regulatory authorities
• Conduct initial and amended contract and budget negotiations with sites
• Maintain filing systems and ensure the Trial Master File is audit ready
• Track start-up progress and ensure sites meet requirements and deadlines
• Ensure accurate and timely system compliance for audit readiness
• Perform CRF review and data validation against source documentation
• Monitor protocol deviations and Serious Adverse Event reporting
• Perform country and site informed consent form review/customization
• Mentor and train junior colleagues when suitable
• Perform other assigned duties

Explore Site Navigator II – Study Start-up Specialist at Fortrea. Review requirements and application details.