Site Navigator II – Study Startup Specialist

Fortrea

Site Navigator II responsible for comprehensive coordination of clinical study start-up activities in Australia. Ensuring regulatory compliance and effective collaboration between sponsors and sites.

Posted 7/8/2026full-timeRemote • 🇦🇺 AustraliaMid-LevelSeniorWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Oversight of site level tasks associated with efficient site activation in accordance with ICH/GCP guidelines, local regulations, SOPs and project requirements
Identifying potential research sites that align with the study's criteria and assessing their capabilities and resources
Conduct initial site outreach, i.e., site engagement, collection of Confidentiality Agreement, and feasibility survey
Remote Pre-Study Visits and follow up documentation, including visit preparation, trip report completion, and other documentation as required
Support customization and translation of informed consent forms and patient-facing materials
Collect, track and perform a quality review of all essential documents required for effective and compliant study site activation
Maintenance and ongoing awareness of site regulatory compliance, supporting IRB/Independent Ethics Committee (IEC) annual renewals, PI change-over, and document expirations
Actively participate in team meetings to facilitate study progress and implement action plans for site level risks, underperforming sites, or issues impacting project milestones
Support the CRA team in preparing for site initiation visits (SIVs)
Responsible for submissions to and liaise with applicable IRB/IEC, Third Bodies, and Regulatory Authorities
Perform initial contract and budget negotiations with the sites
Ensure high quality documents are filed in applicable systems in accordance with SOPs and project requirements and that the Trial Master File (TMF) is updated and audit ready at all times
Track the progress of the start-up process and ensure that the research site meets all requirements and deadlines
Perform Case Report Form (CRF) review and data validation against source documentation according to protocol and guidelines as applicable in combination with monitoring for site protocol deviations.

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
A strong working knowledge of the ICH/GCP guidelines and RA, IRB/IEC regulations
In lieu of the above requirement, candidates with a High School Diploma or equivalent AND a minimum of 5 years' work experience in clinical research will be considered
Fluent in local official language and in English, both written and verbal
Advanced experience in start-up/ regulatory process (TGA and Bellberry)
Advanced knowledge of HREC & RGO submissions, ICH/GCP, RA, IRB/IEC, and other applicable regulations/guidelines
Familiarity with investigator start-up documents and contract/budgets negotiation process
Previous interaction with operational project teams and investigative sites
Ability to manage multiple tasks and deadlines simultaneously, ensuring that all requirements are met in a timely manner
Ability to negotiate contracts and budgets effectively with research sites.

Benefits

Comp & perks

Remote-based work required with possible office presence depending on location
Limited travel for training only

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

Site EngagementFeasibility SurveyCase Report Form ReviewData ValidationTrial Master File ManagementBudget NegotiationIRB/IEC SubmissionsRegulatory Authority LiaisonDocument Quality ReviewStart-Up Process Management

Soft Skills

MultitaskingEffective CommunicationTeam CollaborationProblem SolvingTime Management

Certifications

University/College Degree in Life ScienceNursing CertificationMedical Technology Certification