Clinical Research

• Manage clinical trial investigator sites, including site management, monitoring, and close-out
• Ensure patient safety and quality study execution in accordance with applicable laws, GCP, and sponsor standards
• Manage investigator site relationships and operational activities from site activation through database lock
• Serve as primary contact for assigned investigator sites and coordinate with Site Care Partners, study teams, vendors, and site personnel
• Provide site development, coaching, training, protocol training, and recruitment support
• Conduct onsite and remote/electronic monitoring for site initiation, routine monitoring, and site closure
• Monitor adverse events and serious adverse events and collaborate with the Drug Safety Unit
• Submit TMF documentation, site reports, follow-up letters, protocol deviations, recruitment updates, clinical supply information, study progress, and metrics
• Identify and resolve site issues; develop corrective and preventative actions
• Resolve data queries and conduct investigator site close-out activities
• Oversee investigational product receipt, handling, accounting, storage, and destruction
• Support database release and, where appropriate, perform unblinded monitor responsibilities
• Maintain product, protocol, and therapy-area knowledge and support patient safety and clinical guidance
• Drive quality-event remediation and audit CAPA activities when applicable

Explore Clinical Research Associate at Parexel. Review requirements and application details.