Fortrea is looking for an experienced clinical operations professional to join our team as Senior Site Navigator (remote), with a strong focus on clinical trial start-up activities and advanced in-house CRA responsibilities. This role is ideal for someone with strong start-up expertise who can operate independently, act as a subject matter expert, and take ownership of key processes within a global CRO environment.
Key Responsibilities:
• Lead and oversee site identification, feasibility, and full start-up activities, including site outreach, feasibility questionnaires, and confidentiality agreements, ensuring alignment with study requirements
• Coordinate and manage Ethics Committee, IRB/IEC, and Regulatory Authority submissions, including initial submissions, amendments, and renewals in collaboration with global and local teams
• Drive, review, and track essential regulatory documents to ensure timely, high-quality, and compliant site activation and ongoing site maintenance
• Act as primary point of contact and subject matter expert for investigative sites throughout start-up and study lifecycle, providing guidance and support
• Independently manage and lead site contract and budget negotiations, including amendments where applicable
• Perform remote Pre-Study Visits, documentation, and follow-up activities, and support Site Initiation Visit (SIV) preparation in collaboration with cross-functional teams
• Conduct advanced in-house CRA activities such as document review, CRF review, data validation, and remote monitoring, including SDV/SDR where applicable
• Ensure TMF completeness, audit readiness, and continuous compliance with SOPs, ICH/GCP, and local regulations
• Identify risks, proactively mitigate issues that could delay study timelines, and escalate when needed
• Collaborate closely with CRAs, project teams, regulatory leads, and cross-functional stakeholders to achieve study milestones and ensure patient safety and data integrity
Qualifications
• University degree (life sciences preferred) or equivalent experience in clinical research
• Minimum 3+ years of experience in clinical start-up, regulatory activities, or clinical development
• Strong hands-on experience in end-to-end clinical trial start-up processes
• Proven experience with EC/RA, IRB/IEC submissions, and regulatory documentation
• Solid experience in contract and budget negotiations with investigative sites
• Strong knowledge of ICH/GCP, regulatory requirements, and clinical trial processes
• Excellent organizational skills, attention to detail, and ability to manage multiple priorities independently
• Strong communication skills with the ability to act as a knowledge resource and collaborate effectively across stakeholders
Learn more about our EEO & Accommodations request here.
