Senior Site Navigator

Fortrea

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

Posted 11/12/2026full-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 site management, contract negotiation, and training of junior colleagues. Proficient in ICH/GCP guidelines and effective communication in both local language and English.

Highest-signal resume keywords

Clinical Research ExperienceICH/GCP Guidelines KnowledgeSite ManagementContract NegotiationRegulatory Compliance

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical DevelopmentSite ActivationFeasibility SurveysProtocol Deviation MonitoringCRF ReviewBudget NegotiationRegulatory Authority LiaisonTrial Master File ManagementInformed Consent Form CustomizationSite Activation Document Quality Review

Soft Skills

MentoringCommunicationProblem-SolvingMultitaskingCollaboration

Certifications & Qualifications

Nursing CertificationMedical Technology CertificationLaboratory Technology Certification

Industry Keywords

IRB/IEC RegulationsRegulatory ComplianceClinical Trial RegulationsResearch Protocol RequirementsSite SupportOperational Project TeamsInvestigator Start-Up Documents

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 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
Act as local country expert in study start-up activities
Mentor and train junior colleagues when suitable
Identify and assess potential research sites and their capabilities
Conduct initial 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 site activation documents
Maintain site regulatory compliance, including annual IRB/IEC renewals, PI changes, and document expirations
Participate in study team meetings and develop action plans for site risks, underperforming sites, and milestone-impacting 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
File high-quality documents in applicable systems and keep the Trial Master File audit ready
Track start-up progress and ensure sites meet requirements and deadlines
Maintain accurate system compliance and audit readiness
Serve as primary site contact and ensure timely delivery within scope and budget
Perform CRF review and source data validation, and monitor protocol deviations and SAE reporting
Perform country and site ICF 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 local official language and in English, both 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 process
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
Understanding of relevant clinical trial and research regulations and guidelines
Ability to identify and resolve potential start-up process issues
Ability to negotiate contracts and budgets effectively with research sites

Benefits

Comp & perks

Remote-based work
Limited travel for training only
Possible office presence depending on location