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 processes, regulatory compliance, and site management, with strong negotiation skills for contracts and budgets. Proficient in ICH/GCP guidelines and capable of mentoring junior colleagues while ensuring high-quality documentation and audit readiness.

Highest-signal resume keywords

Clinical Research ExperienceICH/GCP Guidelines KnowledgeRegulatory Compliance ExpertiseContract Negotiation SkillsSite Management Proficiency

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Study Start-UpRegulatory ComplianceFeasibility SurveysSite ActivationCRF ReviewData ValidationProtocol Deviation MonitoringInformed Consent Form CustomizationBudget NegotiationEssential Document Tracking

Soft Skills

Issue ResolutionTask ManagementCommunication SkillsMentoring AbilityCollaboration

Tools & Technologies

Trial Master File SystemsIRB/IEC Submission ProcessesClinical Trial Management Systems

Certifications & Qualifications

University/College Degree in Life ScienceNursing CertificationMedical or Laboratory Technology Certification

Industry Keywords

Clinical DevelopmentInvestigative SitesRegulatory AuthoritiesOperational Project TeamsResearch Protocol Requirements

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
Identify and assess potential research sites
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
Participate in study team meetings and develop action plans for site-level risks and issues
Support CRA teams in preparing site initiation visits and coordinating vendors, 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 sites
Maintain high-quality filing in applicable systems and ensure the Trial Master File is audit ready
Track start-up progress and ensure research sites meet requirements and deadlines
Ensure Fortrea remains audit ready through accurate system compliance
Serve as primary investigative-site contact
Perform CRF review and data validation against source documentation, as applicable
Monitor protocol deviations and Serious Adverse Event reporting
Perform country and site informed-consent-form review/customization
Mentor or train junior colleagues when suitable

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 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 issues during the start-up process
Ability to negotiate contracts and budgets with research sites

Benefits

Comp & perks

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