Site Navigator II – Clinical Study Start‑up Specialist

About the role

The Site Navigator II plays a critical role in coordinating site‑level activities during the start‑up phase of clinical studies and may continue through 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, collaborating with project leadership and monitors.
• 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 according to sponsor and regulatory requirements.
• Customize and translate informed consent forms and patient‑facing materials.
• Collect, track and quality‑review essential documents for site activation, and maintain regulatory compliance throughout the study.
• Support CRA team for site initiation visits, coordinate supplies, and liaise with IRB/IEC and regulatory authorities.
• Negotiate contracts and budgets with sites, ensure TMF is audit‑ready, and serve as primary contact for investigative sites.

Required profile

• University degree in life sciences or related health profession, or equivalent experience (3+ years in clinical research).
• Fluent in the local official language and English, both written and verbal.
• Minimum 2 years of experience in clinical development/start‑up or regulatory processes.
• Strong knowledge of ICH/GCP, regulatory affairs, IRB/IEC regulations and investigator start‑up documentation.
• Proven ability to communicate with site staff, CRO personnel and regulatory authorities.

Required skills

• ICH/GCP guidelines
• Regulatory affairs (RA) compliance
• IRB/IEC processes
• Site contract and budget negotiation
• Document management and TMF maintenance