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Site Navigator II – Regulatory & Start Up Specialist
FortreaSite Navigator II coordinating site-level activities throughout clinical study start-up phases in Australia. Ensuring regulatory compliance, site management, and effective collaboration with stakeholders.
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Perform oversight of site level tasks associated with efficient site activation
- Ensure regulatory compliance, robust site management, optimal site support and training
- Identify potential research sites and assess their capabilities
- Collect, track and perform a quality review of all essential documents
- Maintain and ongoing awareness of site regulatory compliance
- Actively participate in team meetings to facilitate study progress
- Support the CRA team in preparing for site initiation visits
- Responsible for submissions to and liaise with applicable IRB/IEC
- Track the progress of the start-up process and ensure requirements and deadlines are met.
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
- Fluent in local official language and in English, both written and verbal
- Minimum of 2+ years of experience in clinical development or start-up/regulatory process
- Working knowledge of ICH/GCP, RA, IRB/IEC, and other applicable regulations/guidelines
- Familiarity with investigator start-up documents and contract/budgets negotiation process
- Demonstrated understanding of research protocol requirements
- Ability to manage multiple tasks and deadlines simultaneously
- Ability to negotiate contracts and budgets effectively with research sites.
Benefits
Comp & perks- Limited travel requirements for training only
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical researchregulatory compliancesite managementquality reviewICHGCPRAIRBIECresearch protocol
Soft Skills
communicationteam collaborationmultitaskingdeadline managementnegotiation
Certifications
university degreenursing certificationmedical technology certificationlaboratory technology certification