Site Navigator I - Remote US & Canada

Site Navigator I coordinates site-level activities for clinical study start-up and ongoing management at Fortrea. The role manages site activation, regulatory compliance, essential documentation, and serves as the primary contact between sponsors, CROs, and investigative sites, ensuring adherence to ICH/GCP guidelines and local regulations.

Responsibilities

• Oversee site activation tasks including feasibility assessment, initial outreach, and regulatory compliance per ICH/GCP guidelines
• Conduct pre-study visits, prepare documentation, and support site selection in alignment with sponsor and protocol requirements
• Collect, track, and perform quality review of essential documents from outreach through site activation
• Maintain site regulatory compliance including IRB/IEC renewals, PI changes, and document expiration tracking
• Coordinate with CRA teams on site initiation visit preparation and clinical study supply distribution

Requirements

• University/College degree in life science OR allied health certification OR 2-3 years clinical research experience with ICH/GCP knowledge
• High school diploma plus minimum 5 years clinical research experience with strong ICH/GCP and regulatory knowledge (alternative pathway)
• At least one year experience in medical, clinical, pharmaceutical, laboratory research, or related field
• Fluent in local official language and English, written and verbal
• Knowledge of ICH/GCP, regulatory affairs, IRB/IEC regulations, and investigator start-up documents
• Ability to manage multiple tasks, communicate with stakeholders, and resolve compliance issues
• Experience with contract and budget negotiation with research sites