Teams at Parexel

Manage site implementation and monitoring from activation to close-out, ensure GCP/ICH/FDA compliance, oversee safety reporting (AEs/SAEs), support site training, recruitment, TMF and documentation, escalate issues, and collaborate with study teams to meet timelines and quality standards.

Coordinate and manage site activation and start-up deliverables (IIP, IRB/ethics, FDA 1572), support document management throughout study conduct (TMF/eTMF), communicate with study teams and sites, resolve site issues, support audits/inspections, act as SME and mentor, and ensure compliance with GCP and client processes.

The Clinical Research Associate monitors clinical trials, maintains site integrity, ensures compliance, and resolves site issues while supporting investigators.