Remote Clinical Start-Up Navigator

Fortrea; Australia; Remote; AUD 70,000 - 110,000; Full time

Job summary

Fortrea is seeking a Site Navigator in Australia (Victoria) to coordinate start-up activities across investigative sites, ensuring regulatory compliance and efficient activation. You will be the single point of contact for sites, guiding feasibility, outreach, and documentation through to activation and ongoing maintenance.

Responsibilities include managing regulatory submissions, site contracts, budgets, and ensuring audit-ready TMF.

Qualifications

• University/College degree in life sciences or nursing/related field, or equivalent clinical research experience.
• Knowledge of ICH/GCP guidelines and RA, IRB/IEC regulations.
• Fluent in local language and in English, both written and verbal.

Responsibilities

• Oversee site activation tasks per ICH/GCP and SOPs, coordinating with project leadership and local monitors.
• Identify potential sites and assess capabilities and resources for study fit.
• Conduct site outreach, gather Confidentiality Agreement and feasibility surveys.
• Manage site-level activities with independent judgment to support timelines and compliance.
• Coordinate remote pre-study visits, documentation, and site selection aligned with regulations.
• Support translation of informed consent forms and patient materials.
• Ensure TMF and essential documents are audit-ready and compliant.
• Engage in study team meetings to address site risks and escalate issues.
• Assist CRA team with site initiation visits, document distribution, and access provisioning.
• Submit to and liaise with IRB/IEC and regulatory bodies with GRSL support.
• Lead contract and budget negotiations with sites as applicable.
• Monitor and maintain regulatory compliance and study readiness across sites.

Skills

Site coordination

Regulatory knowledge

Communication skills

ICh/GCP knowledge

Project management

Education

Life science degree

Healthcare certification or equivalent experience

HS diploma + 5 years clinical research

Job description

Fortrea is seeking a Site Navigator in Australia (Victoria) to coordinate start-up activities across investigative sites, ensuring regulatory compliance and efficient activation. You will be the single point of contact for sites, guiding feasibility, outreach, and documentation through to activation and ongoing maintenance.

Responsibilities include managing regulatory submissions, site contracts, budgets, and ensuring audit-ready TMF.