Sr Clinical Site Navigator

4 semanas atrás

São Paulo, São Paulo, Brasil Fortrea Tempo inteiro
Sr Clinical Site Navigator (Senior Start-up Specialist)

Join to apply for the Sr Clinical Site Navigator (Senior Start-up Specialist) role at Fortrea .

Job Overview

The Clinical Site Navigator role is a hybrid position that combines start-up and iHCRA/CRA responsibilities. Site Navigators play a critical role in coordinating site-level activities throughout the start-up phase of a clinical trial and potentially through closeout activities. Serving as the single point of contact for investigative sites, this role ensures a smooth progression from feasibility and initial outreach through to site activation, extending through the maintenance phase as required. A key component is ensuring regulatory compliance, robust site management, optimal support and training, and effective collaboration between the sponsor, CRO, and clinical site staff. A scientific degree and/or clinical expertise is preferred.

Summary of Responsibilities

  • Oversee site-level tasks for efficient site activation, ensuring compliance with ICH/GCP guidelines, local regulations, SOPs, and project requirements, in collaboration with project leadership and local monitors.
  • Identify potential research sites, assess their capabilities, and conduct initial outreach, including feasibility surveys and confidentiality agreements.
  • Support documentation for site selection, including remote pre-study visits, visit preparation, and follow-up documentation.
  • Assist in customizing and translating informed consent forms and patient materials.
  • Manage and review essential documents for site activation, maintaining regulatory compliance and supporting renewals and amendments.
  • Participate in team meetings, address site risks or issues, and support the CRA team in preparing for SIVs.
  • Support submissions to IRB/IEC and regulatory authorities in collaboration with the Regulatory Submissions Lead.
  • Negotiate initial contracts and budgets with sites.
  • Ensure accurate documentation and system compliance, tracking start-up progress and meeting deadlines.
  • Maintain audit readiness through consistent system compliance.
  • Serve as the primary contact for investigative sites, ensuring timely delivery of study materials and site preparation for patient enrollment.
  • Perform CRF review and data validation, monitor protocol deviations, SAE reporting, and patient safety issues.

Minimum Qualifications

  • University/College degree in life sciences or related health profession, or equivalent experience with 4+ years in clinical research.
  • Alternative: High school diploma with 5+ years of clinical research experience.
  • Strong knowledge of ICH guidelines, RA, IRB/IEC regulations, and experience with investigator start-up documents.
  • Advanced English proficiency.

Experience

  • Over 4 years in clinical development or regulatory processes.
  • Expertise in applying ICH, RA, IRB/IEC regulations; experience with investigator start-up documents and site interactions.
  • Strong skills in issue resolution, communication, negotiation, and relationship management.
  • Leadership qualities, strategic thinking, resilience, cultural awareness, and a focus on quality and customer service.

Physical Demands/Work Environment

  • Office environment.

Learn more about our EEO & Accommodations here.

Senior level
  • Mid-Senior level
Employment type
  • Full-time
Job function
  • Other, Information Technology, Management
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