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.
Skills Required
- University degree (life sciences preferred)
- Minimum 2+ years of experience in Start‑Up
- Strong hands-on experience in clinical trial start‑up
- 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
What We Do
Fortrea (Nasdaq: FTRE) is a leading global provider of clinical development and patient access solutions to the life sciences industry. We partner with emerging and large biopharmaceutical, medical device and diagnostic companies to drive healthcare innovation that accelerates life changing therapies to patients in need. Fortrea provides phase I-IV clinical trial management, clinical pharmacology, differentiated technology-enabled trial solutions and post-approval services. Fortrea’s solutions leverage three decades of experience spanning more than 20 therapeutic areas, a passion for scientific rigor, exceptional insights and a strong investigator site network. Our talented and diverse team working in more than 90 countries is scaled to deliver focused and agile solutions to customers globally. Learn more about how Fortrea is becoming a transformative force from pipeline to patient at Fortrea.com.
