Sr Clinical Site Navigator

2 semanas atrás

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 #J-18808-Ljbffr

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    Job OverviewThe Clinical Site Navigator role is a hybrid position that combines start-up and iHCRA/CRA responsibilities. Site Navigators play a critical role in the comprehensive coordination of site-level activities throughout the start-up phase of a clinical trial and potentially through closeout activities as required. Serving as the single point of...

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