Site Navigator I

About the Role

Site Navigators play a critical role in the comprehensive coordination of site-level activities throughout the start-up phase of a clinical study. Serving as the single point of contact for investigative sites, this role ensures smooth progression from feasibility and initial outreach through to site activation and maintenance.

Key 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, including site engagement, collection of Confidentiality Agreement, and collection of feasibility surveys.
• Apply independent judgment and discretion in managing site-level activities, resolving issues, and making decisions that support study timelines and compliance requirements.
• Perform Remote Pre-Study Visits and follow-up documentation, including visit preparation and trip report completion.
• Support customization and translation of informed consent forms and patient-facing materials.
• Collect, track, and perform quality review of all essential documents required for compliant study site activation.
• Maintain awareness of site regulatory compliance, supporting annual IRB/Independent Ethics Committee (IEC) renewals, PI changes, and document expirations.
• Actively participate in study team meetings to support study progress and develop action plans for site-level risks.
• Support the CRA team in preparing for site initiation visits (SIVs) by coordinating with vendors and study leads.
• Responsible for submissions to and liaise with applicable IRB/IEC, Third Bodies, 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, and that the Trial Master File (TMF) is updated and audit-ready.
• Track the progress of the start-up process and ensure that research sites meet all requirements and deadlines.
• Ensure Fortrea is audit-ready by completing accurate, timely, and consistent system compliance.
• Serve as primary contact for investigative sites and ensure timely delivery in alignment with scope of work/study budget.
• Perform Case Report Form (CRF) review and data validation against source documentation.
• Monitor for site protocol deviations and Serious Adverse Event (SAE) reporting.
• Perform country and site ICF review/customization, per local requirements.

Requirements & Tech Stack

• ICH/GCP guidelines
• Local regulations
• SOPs
• Confidentiality Agreement
• Informed consent forms
• IRB/Independent Ethics Committee (IEC)
• Trial Master File (TMF)
• Case Report Form (CRF)
• Serious Adverse Event (SAE)
• Remote-based work (with possible office presence)
• Limited travel for training

Qualifications

• University/College degree (life science preferred), or certification in a related allied health profession from an accredited institution (e.g., nursing certification, medical or laboratory technology).
• 2-3 years' work experience in clinical research, including a working knowledge of ICH/GCP guidelines and RA, IRB/IEC regulations.
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
• High School Diploma or equivalent AND a minimum of 5 years' work experience in clinical research, including a strong working knowledge of ICH/GCP guidelines and RA, IRB/IEC regulations, will be considered.
• Fluent in local official language and in English, both written and verbal.

Experience

• A scientific degree and/or clinical expertise is optimal.
• At least one year of experience in a related field (e.g., medical, clinical, pharmaceutical, laboratory research, data analysis, data management or technical writing).
• One year of clinical research is preferred.
• Basic knowledge of ICH/GCP, RA, IRB/IEC, and other applicable regulations/guidelines.
• Familiarity with investigator start-up documents and contract/budgets negotiation process.
• Previous interaction with operational project teams and investigative sites is preferred.
• Demonstrated understanding of research protocol requirements.
• Effective communication with various stakeholders.
• Ability to manage multiple tasks and deadlines simultaneously.
• Understanding of relevant regulations and guidelines related to clinical trials and research.
• Ability to identify and resolve potential issues during the start-up process.
• Ability to negotiate contracts and budgets effectively with research sites.