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Site Navigator II

Maidenhead, England, United Kingdom Full-time Posted 2 weeks ago
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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