Site Navigator II (Regulatory & Start up Specialist) - FSP

Fortrea

Melbourne

5 days ago

Melbourne

5 days ago

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Site Navigator II (Regulatory & Start up Specialist) - FSP

Fortrea is seeking a Site Navigator II (Regulatory & Start-up Specialist) to coordinate site-level activities during the start-up phase of clinical studies. This remote role involves regulatory compliance, site management, and collaboration with sponsors and clinical sites. Candidates need a degree in life sciences or equivalent experience, with at least 2 years in clinical development or start-up/regulatory processes.

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Remote

Full-time

Mid Level

ICH/GCP Guidelines

Regulatory Affairs (RA)

Salary

Not specified

Work Location

Melbourne, Victoria, Australia, AU

Work Model

Remote-based work required with possible office presence depending on location

Experience Required

2 years

Employment Type

Full-time

Experience Level

Mid Level (minimum 2 years experience)

Core Qualifications

Technical (Must-have)

ICH/GCP guidelinesregulatory affairs (RA)IRB/IEC regulationsclinical researchsite managementcontract negotiationbudget negotiationTrial Master File (TMF)Case Report Form (CRF) reviewinformed consent form (ICF) customization

Soft Skills

communicationcollaborationmentoringproblem-solvingtime managementorganizational skillsattention to detailstakeholder management

Tools (Must-have)

Microsoft Office

Key Responsibilities

•Oversee site-level tasks for efficient site activation in compliance with ICH/GCP, local regulations, SOPs, and project requirements.
•Identify potential research sites and assess their capabilities.
•Conduct initial site outreach including confidentiality agreement and feasibility survey.
•Perform remote Pre-Study Visits and 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, including regulatory submissions.
•Actively participate in team meetings to facilitate study progress and escalate issues.
•Support CRA team in preparing for site initiation visits.
•Liaise with IRB/IEC, third bodies, and regulatory authorities.
•Negotiate initial and amended contracts and budgets with sites.
•Ensure TMF is updated and audit-ready.
•Track site start-up progress and ensure deadlines are met.
•Serve as primary contact for investigative sites.
•Perform CRF review and data validation against source documentation.
•Perform country and site ICF review/customization.

clinical researchstart-upregulatorysite managementICH/GCPRemoteFull-timeMid LevelAustraliaFortrea

Core Qualifications

Technical (Must-have)

Soft Skills

communicationcollaborationmentoringproblem-solvingtime managementorganizational skillsattention to detailstakeholder management

Tools (Must-have)

Microsoft Office

Key Responsibilities

•Oversee site-level tasks for efficient site activation in compliance with ICH/GCP, local regulations, SOPs, and project requirements.

•Identify potential research sites and assess their capabilities.

•Conduct initial site outreach including confidentiality agreement and feasibility survey.

•Perform remote Pre-Study Visits and 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, including regulatory submissions.

•Actively participate in team meetings to facilitate study progress and escalate issues.

•Support CRA team in preparing for site initiation visits.

•Liaise with IRB/IEC, third bodies, and regulatory authorities.

•Negotiate initial and amended contracts and budgets with sites.

•Ensure TMF is updated and audit-ready.

•Track site start-up progress and ensure deadlines are met.

•Serve as primary contact for investigative sites.

•Perform CRF review and data validation against source documentation.

•Perform country and site ICF review/customization.