Teams at Fortrea

Oversee clinical trial start-up and delivery from site identification through database lock. Manage timelines, budgets, risks, regulatory and ethics submissions, site selection, contracts, supplies, recruitment, monitoring, quality, documentation, and site payments. Lead client communications and collaborate with global cross-functional teams to ensure compliance, patient safety, data integrity, inspection readiness, and successful trial execution.

Coordinates clinical study site start-up and maintenance activities, including collecting and reviewing essential documents, preparing regulatory and IRB/IEC submissions, tracking approvals, updating electronic systems, and ensuring compliance with ICH/GCP, regulations, SOPs, timelines, and quality standards. Acts as a primary contact for investigative sites and regulatory bodies, supports informed consent customization, contract and budget tracking, risk escalation, and site activation strategy. May mentor less-experienced colleagues and requires frequent domestic and international travel.

Monitors Phase I clinical trial sites, conducts site initiation and close-out visits, verifies informed consent and protocol compliance, reviews clinical data and resolves queries, manages study files and registries, reports serious adverse events, supports project coordination, and trains new employees. The role requires frequent overnight travel and adherence to strict clinical research standards.