Site Navigator II (Study Start-up Specialist) - Brisbane, Perth, Adelaide
Core
Coordinate site-level activities for clinical study start-up, ensuring regulatory compliance and smooth progression from feasibility to site activation.
Role type
Senior IC clinical study start-up specialist
Builds
Clinical trial sites
Domain
Clinical research / Life sciences
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
ICH/GCP guidelines, IRB/IEC regulations, site feasibility assessment, contract negotiation, regulatory submissions, data validation, site training
Preferred skills
Life science degree, clinical expertise, TGA/Belberry regulations knowledge
Technologies
Fortrea, TMF systems
Responsibilities
Conduct initial site outreach and feasibility surveys; coordinate remote pre-study visits and documentation; manage regulatory submissions to IRB/IEC; negotiate site contracts and budgets; perform CRF review and data validation; ensure audit readiness of Trial Master File.
Seniority
Senior, hands-on IC
