Site Navigator I

• Coordinate site-level activities throughout clinical study start-up and potentially closeout
• Serve as the primary point of contact for investigative sites
• Identify and assess potential research sites
• Conduct initial site outreach and collect confidentiality agreements and feasibility surveys
• Manage site-level activities, resolve issues, and support study timelines and compliance
• Conduct remote pre-study visits and complete follow-up documentation
• Support customization and translation of informed consent forms and patient-facing materials
• Collect, track, and quality-review essential site activation documents
• Maintain site regulatory compliance, including IRB/IEC renewals, PI changes, and document expirations
• Participate in study team meetings and develop action plans for site risks and issues
• Support CRA teams in preparing site initiation visits and coordinating supplies, access, and documents
• Liaise with IRB/IEC, Third Bodies, and Regulatory Authorities
• Perform initial and amended contract and budget negotiations with sites
• Maintain accurate filing systems and an audit-ready Trial Master File
• Track start-up progress and site requirements and deadlines
• Ensure ongoing system compliance and audit readiness
• Deliver timely site support within scope of work and study budget
• Perform CRF review and source-data validation, and monitor protocol deviations and SAE reporting
• Perform country and site informed-consent-form review and customization
• Perform other assigned duties

• University/College degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution, or 2–3 years' work experience in clinical research
• Relevant and equivalent experience may be considered in lieu of educational requirements
• High School Diploma or equivalent and a minimum of 5 years' work experience in clinical research may substitute for the above requirement
• Working knowledge of ICH/GCP guidelines and RA, IRB/IEC regulations
• Fluent in the local official language and English, written and verbal
• At least one year of experience in a related field
• Basic knowledge of ICH/GCP, RA, IRB/IEC, and applicable regulations/guidelines
• Familiarity with investigator start-up documents and contract/budget negotiation processes
• Understanding of research protocol requirements
• Ability to manage multiple tasks and deadlines simultaneously
• Ability to identify and resolve potential issues during the start-up process
• Ability to negotiate contracts and budgets with research sites
• Effective communication with site staff, CRO personnel, and regulatory authorities

• Remote-based work required with possible office presence depending on location
• Limited travel, only for training
• EEO & accommodations support