Senior Site Navigator

Senior Site Navigators play a critical role in the comprehensive coordination of site-level activities throughout the start-up phase of a clinical study and potentially through closeout activities as required.

Serving as the single point of contact for investigative sites, this role ensures smooth progression from feasibility and initial outreach through to site activation, extending through the maintenance phase of the study as required.

A crucial component in meeting the requirements of the Senior Site Navigator role is ensuring regulatory compliance, robust site management, optimal site support and training, and effective collaboration between the sponsor, CRO, and clinical site staff.

The Senior Site Navigator serves as local country expert in study start-up activities for a particular country or region.

Summary of Responsibilities:

• Oversight of site level tasks associated with efficient site activation in accordance with ICH/GCP guidelines, local regulations, SOPs and project requirements
• Identifying potential research sites that align with the study's criteria and assessing their capabilities and resources
• Conduct initial site outreach, i.e., site engagement, collection of Confidentiality Agreement, and feasibility survey
• Remote Pre-Study Visits and follow up documentation
• Support customization and translation of informed consent forms and patient-facing materials
• Collect, track and perform a quality review of all essential documents required for effective and compliant study site activation
• Actively participate in study team meetings to support study progress
• Support the CRA team in preparing for site initiation visits (SIVs)
• Responsible for submissions to and liaise with applicable IRB/IEC, Third Bodies (if applicable), and Regulatory Authorities
• Perform initial contract and budget negotiations with the sites
• Ensure high quality documents are filed in applicable systems in accordance with SOPs and project requirements
• Track the progress of the start-up process and ensure that the research site meets all requirements and deadlines
• Ensure Fortrea is audit ready by completing accurate, timely, and consistent system compliance on an ongoing basis
• Serve as primary contact for investigative sites and ensure timely delivery in alignment with scope of work/study budget
• Perform Case Review Form (CRF) review and data validation against source documentation
• Perform country and site ICF review/customization, per local requirements

Qualifications (Minimum Required):

• University/College degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements
• In lieu of the above requirement, candidates with a High School Diploma or equivalent AND a minimum of 5 years' work experience in clinical research
• Fluent in local official language and in English, both written and verbal

Experience (Minimum Required):

• A scientific degree and/ or clinical expertise is optimal for this role
• Minimum of 3+ years of experience in clinical development or start-up/ regulatory process
• Thorough knowledge of ICH/GCP, RA, IRB/IEC, and other applicable regulations/guidelines
• Demonstrated understanding of research protocol requirements and proven ability to communicate them/educate others about them
• Effective communication with various stakeholders, including site staff, CRO personnel, and regulatory authorities
• Ability to manage multiple tasks and deadlines simultaneously
• Understanding of relevant regulations and guidelines related to clinical trials and research

Physical Demands / Work Environment:

• Remote-based work required with possible office presence depending on location
• Travel requirements: Limited for training only