Senior Site Navigator
Remote · São Paulo, São Paulo, Brazil
Job Summary
Senior Site Navigator coordinating start-up activities for clinical studies, serving as the single point of contact for investigative sites, ensuring regulatory compliance and robust site management, overseeing site activation from feasibility through maintenance, mentoring junior staff, and collaborating with sponsor/CRO. Responsibilities include site identification/outreach, feasibility surveys, Confidentiality Agreements, translation/customization of informed consent forms, documentation collection and quality review for TMF, IRB/IEC submissions and renewals, contract and budget negotiations, SIV preparation, vendor coordination, and ensuring patient rights and safety while meeting project milestones. Remote-based role with potential office presence depending on location; requires strong understanding of ICH/GCP, regulatory requirements, and cross-functional coordination with project teams.
Required Qualifications
- University/College degree (life science preferred) or certification in a related allied health profession (e.g., nursing certification, medical or laboratory technology) or 3-5 years' work experience in clinical research with knowledge of ICH/GCP, RA, IRB/IEC regulations; Fortrea may consider equivalent experience; in lieu of above, High School Diploma or equivalent with minimum 5 years' clinical research experience
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