Senior Site Navigator

Fortrea

. Coordinate site-level activities throughout clinical study start-up and potentially closeout .

Posted 11/6/2026full-timeRemote • Mexico, BrazilSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical study start-up and regulatory compliance, with strong capabilities in contract negotiation and site management. Proficient in ICH/GCP guidelines and effective communication in both local language and English.

Highest-signal resume keywords

Clinical Research ExperienceICH/GCP Guidelines KnowledgeContract Negotiation SkillsSite Management ExpertiseRegulatory Compliance Proficiency

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Study Start-UpRegulatory ComplianceSite ActivationFeasibility SurveysCRF ReviewSource-Data ValidationProtocol Deviation MonitoringBudget NegotiationEssential Document TrackingIRB/IEC Submission

Soft Skills

Problem-SolvingMentoringCommunicationTime ManagementCollaboration

Tools & Technologies

Trial Master FileFiling SystemsDocument Management Systems

Certifications & Qualifications

University/College Degree in Life ScienceNursing CertificationMedical Technology Certification

Industry Keywords

Clinical DevelopmentInvestigative SitesRegulatory AuthoritiesResearch ProtocolsIRB/IEC Regulations

About the role

Key responsibilities & impact

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 outreach through activation and maintenance
Ensure regulatory compliance, site management, site support and training, and collaboration among sponsor, CRO, and clinical site staff
Act as local country expert in study start-up activities
Mentor and train junior colleagues when appropriate
Identify and mitigate issues that could delay studies
Identify and assess potential research sites
Conduct site outreach, confidentiality agreement collection, and 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 renewals, PI changes, and document expirations
Participate in study team meetings and develop action plans for 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 high-quality filing systems and an audit-ready Trial Master File
Track start-up progress and site requirements and deadlines
Maintain ongoing system compliance to ensure Fortrea is audit ready
Serve as primary contact for investigative sites and ensure timely delivery within scope and budget
Perform CRF review and source-data validation, monitor protocol deviations and SAE reporting
Perform country and site informed-consent-form review and customization
Perform other assigned duties

Requirements

What you’ll need

University/College degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution (e.g., nursing certification, medical or laboratory technology), or 3–5 years' work experience in clinical research
Relevant and equivalent experience may be considered in lieu of educational requirements
High School Diploma or equivalent and a minimum of 5 years' work experience in clinical research may be considered in lieu of the above requirement
Strong working knowledge of ICH/GCP guidelines and RA, IRB/IEC regulations
Fluent in the local official language and English, written and verbal
Minimum of 3+ years of experience in clinical development or start-up/regulatory process
Thorough knowledge of ICH/GCP, 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
Understanding of research protocol requirements and ability to communicate and educate others about them
Ability to manage multiple tasks and deadlines simultaneously
Ability to identify and resolve potential start-up issues
Ability to negotiate contracts and budgets effectively with research sites

Benefits

Comp & perks

Remote-based work required with possible office presence depending on location
Limited travel for training only
EEO and accommodations support