Teams at Fortrea

Manages and monitors clinical trial sites in compliance with ICH GCP, regulatory requirements, SOPs, and study plans. Conducts site initiation, routine monitoring, source data verification, eCRF review, query resolution, regulatory document review, investigational product accountability, and audit-readiness activities. Maintains trial systems, prepares monitoring reports and plans, follows up on safety events, supports investigator and study-team meetings, and may train site staff and new employees. The role requires independent site management and approximately 60% travel from Sydney.

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.