Jobs 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.

Monitor clinical trial sites from initiation through close-out, ensuring protocol adherence, data integrity, regulatory compliance (ICH-GCP), site training and issue resolution. Conduct on-site and remote visits, update CTMS/TMF/EDC, manage supply/accountability, follow up on CRF queries and SAEs, support recruitment strategies, and maintain audit/inspection readiness while working independently within cross-functional teams.

Provide regulatory consulting and project execution within clinical development projects. Support project planning, client interactions, risk identification, financials, and deliverables. Mentor junior staff, contribute to business development, and ensure team compliance with processes and training. May lead small projects or workstreams and act as main client contact when serving as Project Lead.

The role involves supporting regulatory teams, managing licensing processes, coordinating documentation, maintaining compliance, and engaging in client communications. Project leadership and business development are also key responsibilities.