Navigator

• Coordinate site-level activities throughout clinical study start-up and potentially closeout
• Serve as the primary point of contact for investigative sites
• Identify and assess potential research sites
• Conduct initial site outreach and collect confidentiality agreements and feasibility surveys
• Manage site-level activities, resolve issues, and support study timelines and compliance
• 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
• Support IRB/IEC renewals, PI changes, and document expiration management
• Participate in study team meetings and develop action plans for site-level risks and issues
• Support CRA teams in preparing site initiation visits and coordinating supplies, 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 quality in applicable systems and keep the Trial Master File audit ready
• Track start-up progress and ensure sites meet requirements and deadlines
• Maintain Fortrea system compliance and audit readiness
• Ensure timely delivery to investigative sites within scope and budget
• Perform CRF review, source data validation, and monitoring of protocol deviations and SAE reporting
• Perform country and site informed consent form review and customization
• Perform other assigned duties

Explore Site Navigator at Fortrea. Review requirements and application details.