Site Navigator II (Study Start-up Specialist) - we're growing the team
Core
Coordinate site-level activities for clinical study start-up, from feasibility and outreach through activation and maintenance, ensuring regulatory compliance and smooth progression for investigative sites.
Role type
Senior IC clinical study start-up specialist (Site Navigator)
Builds
Clinical trial start-up processes and site activation for pharmaceutical/biotech studies
Domain
Clinical research / Clinical trials
Required skills
ICH/GCP guidelines, IRB/IEC regulations, site feasibility assessment, contract and budget negotiation, regulatory submissions, data validation, stakeholder management, project tracking
Preferred skills
Life science degree, clinical expertise, experience with TGA/Belberry regulations, vendor coordination
Technologies
Fortrea, TMF systems, CRF systems
Responsibilities
Conduct initial site outreach and feasibility surveys; coordinate remote pre-study visits and documentation; support customization of informed consent forms; liaise with IRB/IEC and regulatory authorities; negotiate contracts and budgets with sites; track start-up progress and ensure audit readiness; perform CRF review and data validation; manage site activation milestones.
Seniority
Senior, hands-on IC
