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Fortrea

Clinical Start-up Specialist

Clinical Start-up Specialist

Posted 2 weeks ago

MaidenheadRemote

Clinical Start-up Specialist

Fortrea

Permanent
Full-Time
Sign up to unlock the estimation.Sign up to unlock the estimation~£35,000 - £45,000per annum· Meev estimate

Posted 2 weeks ago

Description

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.
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Fortrea

A global CRO advancing clinical trials from Phase I to IV with tailored solutions

DurhamContract Research1000+
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Fortrea

Contract Research

Shape the future of medicine by working on trials that deliver treatments patients need. Collaborate across 90 countries with scientists, clinicians, and strategists driving innovation in clinical development every day.

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Fortrea logo

Fortrea

Contract Research

Shape the future of medicine by working on trials that deliver treatments patients need. Collaborate across 90 countries with scientists, clinicians, and strategists driving innovation in clinical development every day.

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