Site Navigator II

Fortrea

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

Posted 11/6/2026full-timeRemote • Mexico, BrazilJuniorMid-LevelWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in coordinating clinical study activities, ensuring regulatory compliance, and managing site interactions. Proficient in contract negotiations, site activation processes, and maintaining high-quality documentation for clinical trials.

Highest-signal resume keywords

Clinical Research ExperienceICH/GCP Guidelines KnowledgeContract Negotiation SkillsRegulatory Compliance ManagementEffective Communication Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Site ActivationFeasibility SurveysCase Report Form ReviewSource-Data ValidationProtocol Deviation MonitoringInformed Consent Form CustomizationRegulatory Authority LiaisonTrial Master File ManagementBudget NegotiationClinical Development Process

Soft Skills

Effective CommunicationTask ManagementProblem-SolvingCollaborationTime Management

Certifications & Qualifications

University/College Degree in Life ScienceNursing CertificationMedical Technology Certification

Industry Keywords

Clinical TrialsIRB/IEC RegulationsResearch ProtocolsRegulatory AuthoritiesCRO CollaborationSite ManagementClinical Study Start-UpInvestigative SitesEssential Document TrackingClinical Development

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
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

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
Fortrea may consider relevant and equivalent experience 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
Familiarity with investigator start-up documents and contract/budgets 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
Effective communication with site staff, CRO personnel, and regulatory authorities
Ability to manage multiple tasks and deadlines simultaneously
Understanding of clinical trial and research regulations and guidelines
Ability to identify and resolve potential 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