Site Navigator II

Fortrea

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

Posted 11/12/2026full-timeRemote • Mexico, BrazilMid-LevelSeniorWebsite

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 effective communication with stakeholders. Proficient in ICH/GCP guidelines and experienced in mentoring junior colleagues.

Highest-signal resume keywords

Clinical Research ExperienceICH/GCP Guidelines KnowledgeContract Negotiation SkillsRegulatory Compliance ExpertiseEffective Communication

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Site ManagementFeasibility SurveysCRF ReviewSource-Data ValidationProtocol-Deviation MonitoringSAE ReportingRegulatory Authority LiaisonTrial Master File ManagementBudget NegotiationDocument Quality Review

Soft Skills

Problem-SolvingTime ManagementMentoringCollaborationEffective Communication

Certifications & Qualifications

University/College Degree in Life ScienceNursing CertificationMedical Technology Certification

Industry Keywords

Clinical DevelopmentIRB/IEC RegulationsRegulatory AffairsInvestigator Start-Up DocumentsOperational Project Teams

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 change-over, and document expiration management
Participate in team meetings, implement action plans, and escalate 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 compliant filing systems and keep the Trial Master File audit ready
Track start-up progress and site requirements/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, source-data validation, protocol-deviation monitoring, and SAE reporting as applicable
Perform country and site informed-consent-form review and customization
Mentor and train junior colleagues when appropriate

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
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 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
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
Possible office presence depending on location