Clinical Start-up Specialist

Fortrea is looking for an experienced clinical operations professional to join our team as Site Navigator II (remote), with a strong focus on clinical trial start‑up activities and in-house CRA responsibilities. This role is ideal for someone with solid start‑up expertise who is ready to take ownership of key processes within a global CRO environment.

Key Responsibilities

• Manage site identification, feasibility, and full start‑up activities, including site outreach, feasibility questionnaires, and confidentiality agreements
• Lead and coordinate Ethics Committee and Regulatory Authority submissions, including initial submissions and amendments
• Drive and track essential regulatory documents to ensure timely and compliant site activation
• Act as primary point of contact for investigative sites during start‑up and early study phases
• Independently manage site contract and budget negotiations in collaboration with internal stakeholders
• Perform remote Pre‑Study Visits and support Site Initiation Visit preparation
• Conduct in‑house CRA activities such as document review, CRF review, data validation, and remote monitoring tasks
• Ensure TMF completeness and inspection readiness
• Collaborate closely with CRAs, project teams, and cross‑functional stakeholders to meet study timelines

Qualifications

• University degree (life sciences preferred)
• Minimum 2+ years of experience in Start‑Up
• Strong hands-on experience in clinical trial start‑up is essential
• Proven experience with EC/RA submissions and regulatory documentation
• Solid experience in contract and budget negotiations
• Good knowledge of ICH/GCP and clinical trial processes
• Strong organizational skills, attention to detail, and proactive communication
• Ability to manage multiple priorities independently in a structured way

Learn more about our EEO & Accommodations request here.

At Fortrea, we're all about turning the “impossible” into "I'm possible." Together, we break barriers to deliver exceptional service to our patients, fueled by a shared commitment to teamwork and excellence. Regardless of your role, we're all family, working together to achieve extraordinary results. At Fortrea, your career isn't just a job – it's a journey of making the exceptional possible, every day.