Site Navigator I

Job Overview:

Site Navigators play a critical role in the comprehensive coordination of site-level activities throughout the start-up phase of a clinical study and potentially through closeout activities as required. Serving as the single point of contact for investigative sites, this role ensures smooth progression from feasibility and initial outreach through to site activation, extending through the maintenance phase of the study as required. A crucial component in meeting the requirements of the Site Navigator role is ensuring regulatory compliance, robust site management, optimal site support and training, and effective collaboration between the sponsor, CRO, and clinical site staff.

Summary of Responsibilities:

• Lead site start-up and activation activities, ensuring compliance with ICH-GCP, local regulations, and study requirements.

• Support EC/IRB submissions, regulatory documentation, and site activation deliverables.

• Manage essential documents, TMF maintenance, and ongoing site compliance activities.

• Conduct feasibility assessments, remote site interactions, and selected IHCRA activities.

• Serve as the primary point of contact for investigative sites and collaborate closely with CRAs, Regulatory Leads, and project teams

Qualifications & Experience (Minimum Required):

• Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field.

• 2+ years of experience in clinical research, preferably within Site Start-Up, Regulatory, IHCRA, or CRA functions.

• Experience with EC/IRB submissions, regulatory documentation, TMF management, contract and budget negotiations, and site activation activities.

• Understanding of ICH-GCP, local regulations, and clinical trial processes.

• Fluent English communication skills, both written and verbal.

• Previous CRA or IHCRA experience is highly preferred

What We're Looking For:

• A scientific degree and/ or clinical expertise is optimal for this role.

• Strong attention to detail and ability to follow SOPs and study procedures.

• Ability to manage multiple priorities in a fast-paced environment.

• Collaborative mindset aligned with Fortrea FOUR culture and values.

• Willingness to perform both Site Start-Up and IHCRA responsibilities, including feasibility and remote site activities.

Learn more about ourEEO & Accommodations request here.