Fortrea is looking for an experienced clinical operations professional to join our team as Senior Site Navigator, 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 3+ 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
- Degree in life sciences
- Minimum 3+ years start-up experience
- Hands-on clinical trial start-up experience
- Experience with Ethics Committee and Regulatory Authority submissions
- Experience in contract and budget negotiations
- Knowledge of ICH/GCP and clinical trial processes
- Experience performing CRA activities (document review, CRF review, data validation, remote monitoring)
- TMF management and inspection readiness experience
- Strong organizational skills and proactive communication
- Ability to manage multiple priorities independently
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.
