Site Navigator II

Fortrea

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

Posted 11/12/2026full-timeRemote • Mexico, BrazilJuniorMid-LevelWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical study start-up processes, regulatory compliance, and site management, with strong capabilities in contract negotiation and effective communication with stakeholders. Proficient in ICH/GCP guidelines and regulatory authority interactions, ensuring audit readiness and quality document management.

Highest-signal resume keywords

Clinical Research ExperienceICH/GCP Guidelines KnowledgeRegulatory Compliance ManagementContract Negotiation SkillsEffective Communication

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Study Start-UpSite ManagementFeasibility SurveysDocument Quality ReviewProtocol Deviation MonitoringInformed Consent CustomizationBudget NegotiationTrial Master File ManagementRegulatory Authority LiaisonSite Activation

Soft Skills

Effective CommunicationProblem-SolvingMultitaskingCollaborationRisk Management

Certifications & Qualifications

University/College Degree in Life ScienceNursing CertificationMedical Technology Certification

Industry Keywords

Clinical DevelopmentIRB/IEC RegulationsResearch Protocol RequirementsClinical Trial RegulationsSite Activation Process

About the role

Key responsibilities & impact

Coordinate site-level activities throughout the clinical study start-up phase and potentially through 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 potential research sites and assess their capabilities and resources
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 documents for site activation and ongoing regulatory compliance
Support IRB/IEC annual renewals, PI changes, and document expiration tracking
Participate in team meetings, implement action plans, and escalate site-level risks and issues
Support CRA teams with site initiation visit preparation, vendors, supplies, access, and document coordination
Submit to and liaise with IRB/IEC, Third Bodies, and Regulatory Authorities
Perform 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
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 and source-data validation, and 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+ 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 2+ years of experience in clinical development or start-up/regulatory process
Working 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
Demonstrated understanding of research protocol requirements
Effective communication with site staff, CRO personnel, and regulatory authorities
Ability to manage multiple tasks and deadlines simultaneously
Understanding of relevant clinical trial and research regulations and guidelines
Ability to identify and resolve issues during the start-up process
Ability to negotiate contracts and budgets effectively with research sites

Benefits

Comp & perks

Remote-based work
Limited travel for training only