Navigator

• Coordinate site-level activities throughout clinical study start-up and potentially closeout
• Serve as the single 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
• Support IRB/IEC annual renewals, PI change-over, and document expiration management
• Participate in team meetings, implement action plans, and escalate site-level risks and issues
• Support CRA teams with site initiation visit preparation, vendor coordination, supplies, access, and document distribution
• Submit to and liaise with IRB/IEC, Third Bodies, and Regulatory Authorities
• Perform initial and amended contract and budget negotiations with sites
• Maintain compliant filing systems and keep the Trial Master File audit ready
• Track start-up progress and site requirements/deadlines
• Ensure Fortrea remains audit ready through accurate system compliance
• Serve as primary investigative-site contact and ensure timely delivery within scope and budget
• Perform CRF review, source-data validation, protocol-deviation monitoring, and SAE reporting as applicable
• Perform country and site informed-consent-form review and customization
• Mentor and train junior colleagues when appropriate

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

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