Job Description

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.

of Responsibilities:

• Coordinate and oversee site start-up and activation activities in compliance with ICH-GCP, local regulations, SOPs, and study requirements

• Identify, assess, and engage potential investigative sites, including feasibility and initial outreach activities

• Manage collection, tracking, and quality review of essential site and regulatory documents

• Support IRB/IEC submissions and maintain ongoing site regulatory compliance

• Collaborate with study teams, CRAs, vendors, and regulatory partners to achieve study milestones

• Track start-up progress, manage timelines, identify risks or issues, and escalate as needed

• Support site onboarding activities including PSV follow-up and SIV preparation

• Maintain inspection-ready TMF and ensure systems and audit compliance

• Serve as the primary point of contact for sites, ensuring timely communication and delivery aligned with study scope

• All other duties as needed or assigned

Qualifications (Minimum Required):

• Bachelor’s degree in Life Sciences or a related field, or equivalent clinical research experience

• Minimum 1–3 years of experience in clinical research or a related field

• Working knowledge of ICH-GCP and local regulatory requirements (RA, IRB/IEC)

• Experience with site start-up activities, feasibility, or site coordination is preferred

• Fluency in English and the local language (written and verbal)

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