Remote Clinical Site Activation Lead

Fortrea; Australia; Remote; AUD 110,000 - 150,000; Full time

Job summary

Fortrea in Australia seeks a Site Navigators II to coordinate site start-up activities across regulatory, site management and training to support clinical studies. You will act as a local expert, mentor junior colleagues, and maintain audit-ready TMF while collaborating with sponsor, CRO and site staff.

Role is remote-based with occasional travel for training. Requires 2+ years in clinical start-up and strong ICH/GCP knowledge, plus a life science degree or equivalent experience.

Qualifications

• 2+ years in clinical start-up/regulatory process (RGO and Ethics submissions)
• Solid knowledge of ICH/GCP guidelines and RA/IRB/IEC regulations
• Experience negotiating contracts and budgets with sites
• Strong communication with site staff, CROs and regulatory authorities
• Ability to manage multiple tasks and meet deadlines

Responsibilities

• Oversee site activation tasks per ICH/GCP, local regulations, SOPs and project requirements
• Identify suitable research sites and assess capabilities
• Conduct site outreach, confidentiality agreements, and feasibility surveys
• Support site initiation visits (SIVs) coordination and documentation
• Coordinate TMF filing and ensure audit readiness
• Coordinate regulatory submissions with GRSL and IRB/IEC
• Negotiate contracts and budgets with sites and amendments as needed
• Ensure regulatory compliance and timely delivery of study milestones

Skills

Clinical start-up experience

ICH/GCP knowledge

Regulatory submissions

Contract/budget negotiation

Stakeholder communication

Training/mentoring

Education

Life science degree

Job description

Fortrea in Australia seeks a Site Navigators II to coordinate site start-up activities across regulatory, site management and training to support clinical studies. You will act as a local expert, mentor junior colleagues, and maintain audit-ready TMF while collaborating with sponsor, CRO and site staff.

Role is remote-based with occasional travel for training. Requires 2+ years in clinical start-up and strong ICH/GCP knowledge, plus a life science degree or equivalent experience.