Site Navigator II – Clinical Study Start‑up

About the role

The Site Navigator II is responsible for coordinating all site‑level activities during the start‑up phase of a clinical study and, when required, through study close‑out. Acting as the single point of contact for investigative sites, the role ensures smooth progression from feasibility to site activation and ongoing maintenance.

Key responsibilities

• Oversee site activation tasks 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 site selection.
• Customize and translate informed consent forms and patient‑facing materials.
• Collect, track, and quality‑review essential documents from outreach to site activation.
• Maintain regulatory compliance, support IRB/IEC renewals, PI changes and document expirations.
• Participate in team meetings, manage site‑level risks, and escalate issues promptly.
• Assist CRA teams in preparing for site initiation visits, coordinating supplies and documentation.
• Liaise with IRB/IEC, third‑party bodies and regulatory authorities in collaboration with Global Regulatory Submissions Lead.

Required profile

• Strong knowledge of clinical trial start‑up processes and regulatory requirements.
• Experience working with investigative sites and coordinating multi‑stakeholder projects.
• Ability to work independently with limited oversight and mentor junior colleagues.
• Excellent organizational and communication skills.

Required skills

• Knowledge of ICH/GCP guidelines.
• Regulatory compliance expertise.