Site Navigator II coordinates clinical study site activation and ongoing management for Fortrea, serving as the primary contact between sponsor, CRO, and investigative sites. The role ensures regulatory compliance, site readiness, and protocol adherence throughout study phases from feasibility through closeout in Mexico City.
Responsibilities
Oversee site activation tasks and regulatory compliance in accordance with ICH/GCP and local regulations
Conduct site outreach, feasibility assessments, and pre-study visits with documentation and follow-up
Collect, track, and review essential regulatory documents from outreach through site activation and maintenance
Coordinate with IRB/IEC and regulatory authorities on submissions and compliance renewals




Support case report form review, data validation, and protocol deviation tracking
Requirements
University degree in life sciences or equivalent clinical research certification/allied health credential
Minimum 2 years clinical development, start-up, or regulatory process experience
Strong working knowledge of ICH/GCP guidelines, regulatory affairs, and IRB/IEC regulations
Fluent in Spanish and English, both written and verbal
Familiarity with investigator start-up documents and contract negotiation processes

📌 Site Navigator Ii (Xico)
🏢 Fortrea
📍 Xico