Site Navigator I – Clinical Study Coordination

About the role

The Site Navigator I supports the end‑to‑end coordination of clinical study sites, acting as the primary point of contact from feasibility through activation and ongoing maintenance. This role ensures regulatory compliance, efficient site management, and seamless collaboration between sponsors, CROs, and site staff.

Key responsibilities

• Oversee site‑level tasks for activation in line with ICH/GCP, local regulations, SOPs and project requirements.
• Identify and assess potential research sites, conduct initial outreach, collect confidentiality agreements and feasibility surveys.
• Perform remote pre‑study visits, prepare documentation, and support translation of informed consent and patient‑facing materials.
• Collect, track and quality‑review essential documents from outreach to site activation, and maintain ongoing regulatory compliance.
• Participate in study team meetings, develop action plans for site risks, and escalate issues promptly.
• Assist CRA teams in preparing site initiation visits by coordinating supplies, vendors and study leads.
• Liaise with IRB/IEC, third‑party bodies and regulatory authorities, and support contract and budget negotiations.

Required profile

• Strong understanding of ICH/GCP guidelines and local regulatory requirements.
• Ability to exercise independent judgment in managing site activities and resolving issues.
• Experience in coordinating multi‑stakeholder clinical study processes.
• Excellent organizational skills to track documents, timelines and compliance activities.

Required skills

What we offer

• Opportunity to work on global clinical studies with leading sponsors and CROs.
• Professional development in clinical research operations.