About the role

Site Navigator coordinating clinical-trial site activation for Fortrea, a clinical research organization advancing life-saving therapies. Managing regulatory documents, site relationships, contracts, and study-startup milestones.

Responsibilities

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 remote pre-study visits and follow-up documentation
Support customization and translation of informed consent forms and patient-facing materials
Collect, track, and quality-review essential documents required for site activation
Maintain site regulatory compliance and support IRB/IEC renewals, PI changes, and document expirations
Participate in study team meetings and develop action plans for site-level risks and issues
Support CRA teams with site initiation visit preparation and coordination of supplies, access, and documents
Submit to and liaise with IRB/IEC, Third Bodies, and Regulatory Authorities
Conduct initial and amended contract and budget negotiations with research sites
Maintain audit-ready filing systems and update the Trial Master File
Track start-up progress and ensure sites meet requirements and deadlines
Serve as primary contact for investigative sites and ensure timely delivery within scope and 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
Complete other assigned duties throughout the study

University/College degree in a relevant field, life science preferred, or certification in a related allied health profession
Alternatively, 2–3 years of clinical research work experience may substitute for educational requirements
Alternatively, a High School Diploma or equivalent and at least 5 years of clinical research experience
At least 1 year of experience in a related field
One year of clinical research experience preferred
Working knowledge of ICH/GCP guidelines and RA, IRB/IEC regulations
Familiarity with investigator start-up documents and contract/budget negotiation processes
Understanding of research protocol requirements
Fluent in the local official language and English, written and verbal
Ability to manage multiple tasks and deadlines
Ability to identify and resolve start-up issues
Ability to negotiate contracts and budgets with research sites
Ability to use in-house and off-the-shelf computer software
Ability to sit for extended periods and operate a vehicle safely
Regular and consistent attendance; varied hours may be required