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.
Required Experience:
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