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 changeovers, and document expiration management
• Participate in team meetings, implement action plans for site risks and issues, and escalate issues timely
• Support CRA teams with site initiation visit preparation and coordinate clinical study 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 research sites
• Maintain high-quality filing systems and keep the Trial Master File audit ready
• Track start-up progress and ensure sites meet requirements and deadlines
• Maintain accurate and timely system compliance to keep Fortrea audit ready
• Serve as primary contact for investigative sites and ensure delivery within scope and budget
• Perform Case Report Form review and source-data validation, monitor protocol deviations and Serious Adverse Event reporting
• Perform country and site informed-consent-form review and customization
• Perform other assigned duties

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

Navigator jobs in Brazil

Site Navigator II

Senior Site Navigator