Teams at Fortrea

Supports clinical trial site startup and maintenance activities by collecting, reviewing, tracking, and filing essential regulatory documents. Assists with IRB/IEC and regulatory submissions, country-specific patient materials, status reporting, vendor communication, issue escalation, and study system updates. Ensures activities meet client expectations, ICH/GCP, SOPs, budgets, quality standards, and applicable laws. Works under supervision and helps maintain audit-ready study documentation.

The Senior Clinical Research Associate I monitors clinical study sites, ensures compliance, manages data integrity, and mentors junior staff while traveling extensively to support clinical trials.

Coordinate and manage site start-up activities for clinical trials including site identification, outreach, regulatory/ethics submissions, document collection and quality review, contract and budget negotiation, support for SIVs, TMF maintenance, and stakeholder communication to ensure compliant and timely site activation.