Site Navigator II – Study Start-up Specialist

Fortrea

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

Posted 10/7/2026full-timeSydney • AustraliaJuniorMid-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 a strong focus on ICH/GCP guidelines and effective contract negotiation. Proficient in coordinating site-level activities and mentoring junior colleagues while ensuring audit readiness and timely compliance.

Highest-signal resume keywords

Clinical Start-Up ProcessRegulatory ComplianceICH/GCP GuidelinesContract NegotiationSite Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical ResearchFeasibility SurveysProtocol Deviation MonitoringCRF ReviewData ValidationInformed Consent Form CustomizationBudget NegotiationSite ActivationRegulatory SubmissionsTrial Master File Management

Soft Skills

CommunicationMentoringProblem SolvingTime ManagementCollaboration

Certifications & Qualifications

University/College Degree in Life ScienceNursing CertificationMedical Technology Certification

Industry Keywords

IRB/IEC RegulationsTGA GuidelinesBelberry RegulationsClinical Trial RegulationsResearch Protocol Requirements

About the role

Key responsibilities & impact

Coordinate site-level activities throughout the clinical study start-up phase and potentially closeout activities
Serve as the primary 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
Participate in team meetings, implement site-level risk action plans, and escalate issues
Support CRA teams with site initiation visit preparation and coordinate vendors, supplies, site 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 filing systems and ensure the Trial Master File is audit ready
Track start-up progress and ensure sites meet requirements and deadlines
Ensure accurate and timely system compliance for audit readiness
Perform CRF review and data validation against source documentation
Monitor protocol deviations and Serious Adverse Event reporting
Perform country and site informed consent form review/customization
Mentor and train junior colleagues when suitable
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 the local official language and English, written and verbal
Minimum of 2+ years of experience in clinical start-up/regulatory process, including RGO and Ethics submissions
Working knowledge of TGA, Belberry, 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
Ability to communicate and educate others about research protocol requirements
Ability to manage multiple tasks and deadlines simultaneously
Understanding of 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

Hybrid/remote-based work arrangement
Possible office presence depending on location
Limited travel for training only
EEO and accommodations support