The Site Navigator II manages site identification, feasibility, and start-up activities, coordinates regulatory submissions, and acts as a point of contact for investigative sites.
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.
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