At a Glance
- Tasks: Lead clinical trial start-up activities and manage site operations remotely.
- Company: Fortrea, a global CRO focused on innovative clinical research.
- Benefits: Flexible remote work, competitive salary, and opportunities for professional growth.
- Other info: Join a collaborative environment with a focus on patient safety and data integrity.
- Why this job: Make a real impact in clinical trials while working with a dynamic team.
- Qualifications: 3+ years in clinical start-up and strong regulatory knowledge required.
The predicted salary is between 50000 - 65000 £ per year.
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 escalations 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.
Senior Site Navigator in Maidenhead employer: FTMAI Fortrea Development Ltd
Fortrea is an exceptional employer that values the expertise and independence of its employees, particularly in the role of Senior Site Navigator. With a strong commitment to employee growth, Fortrea offers a collaborative work culture that encourages innovation and professional development within the dynamic field of clinical research. The remote nature of this position allows for flexibility while being part of a global team dedicated to advancing clinical trials and ensuring patient safety.
Contact Details:
FTMAI Fortrea Development Ltd Recruitment Team
