Sr Clinical Site Navigator

Há 3 dias

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
#J-18808-Ljbffr

  • Clinical Site Navigator

    Há 3 dias

    São Paulo, São Paulo, Brasil Fortrea Tempo inteiro

    Clinical Site Navigator (Start-up Specialist II) Join to apply for the Clinical Site Navigator (Start-up Specialist II) role at Fortrea Clinical Site Navigator (Start-up Specialist II) 1 day ago Be among the first 25 applicants Join to apply for the Clinical Site Navigator (Start-up Specialist II) role at Fortrea The Clinical Site Navigator role is a...

  • Clinical Site Navigator

    Há 7 dias

    São Paulo, São Paulo, Brasil Fortrea Tempo inteiro US$80.000 - US$120.000 por ano

    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 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...

  • Clinical Site Navigator

    Há 6 dias

    São Paulo, São Paulo, Brasil Fortrea Tempo inteiro R$60.000 - R$120.000 por ano

    The 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 contact for...

  • Sr Clinical Site Navigator

    Há 6 dias

    São Paulo, São Paulo, Brasil Fortrea Tempo inteiro R$900.000 - R$1.200.000 por ano

    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 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...

  • Site Activation Specialist

    Há 2 dias

    São Paulo, São Paulo, Brasil beBeeClinical Tempo inteiro US$82.300 - US$106.995

    Job OverviewThe Clinical Site Navigator is a hybrid role that combines startup and clinical research associate (CRA) responsibilities. Their primary objective is to coordinate site-level activities throughout the startup phase of a clinical trial, ensuring a smooth progression from feasibility to site activation.

  • Clinical Trial Site Engagement Sr Manager

    4 semanas atrás

    São Paulo, São Paulo, Brasil Amgen Tempo inteiro

    Clinical Trial Site Engagement Sr ManagerDevelop, implement and maintain an integrated site engagement and operational role at key/targeted sites in line with Global Development pipeline to support strategic global study strategy plan to accelerate development of marketed products and early pipeline assets. Maintains an effective collaborative partnership...

  • Sr. Site Manager – Sr. Cra

    Há 2 dias

    São Paulo, São Paulo, Brasil Johnson & Johnson Innovative Medicine Tempo inteiro

    Sr.Site Manager – Sr.CRA (Clinical Research Associate)Join to apply for the Sr.Site Manager – Sr.CRA (Clinical Research Associate) role at Johnson & Johnson Innovative MedicineSr.Site Manager – Sr.CRA (Clinical Research Associate)Join to apply for the Sr.Site Manager – Sr.CRA (Clinical Research Associate) role at Johnson & Johnson Innovative...

  • Study Site Coordinator

    Há 2 dias

    São Paulo, São Paulo, Brasil beBeeClinical Tempo inteiro US$60.000 - US$80.000

    Clinical Site Navigator Role">We are seeking an experienced and highly organized individual to fill the role of Clinical Site Navigator. This key position will play a critical part in coordinating site-level activities throughout the start-up phase of clinical trials.">Key Responsibilities:Oversight of site-level tasks associated with efficient site...

  • Sr. Site Contracts Associate/Site Contracts Associate

    Há 3 dias

    São Paulo, São Paulo, Brasil IQVIA Argentina Tempo inteiro

    IQVIA Biotech is hiring for Sr. Site Contracts Associate or Site Contracts Associate in Brazil with experience negotiating clinical site contracts and budget templates. Grant Plan a plus. 3-5 years' experience for Senior level and 1-3 years at the Site Contract Associate level:Job OverviewDevelop the global contracting strategy and support the delivery of...

  • Clinical Project Assistant

    Há 3 dias

    São Paulo, São Paulo, Brasil CTI Clinical Trial Services, Inc Tempo inteiro

    **Clinical Project Assistant****Job Purpose/Summary**Responsible for supporting management efforts of Clinical Project Managers and Directors, ensuring timelines, and quality standards are being achieved.**What You'll Do**- Support Clinical Project Manager / Director in completing management activities; supports activities through all phases of a clinical...