Parexel
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Pharmaceutical
Lead and perform site monitoring activities from activation through close-out, ensuring GCP compliance, patient safety, data quality, SAE handling, TMF and reporting. Serve as primary site contact, support recruitment and training, collaborate with study team, drive CAPA and audit responses, and provide oversight of investigational product and site performance.
Pharmaceutical
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.
Pharmaceutical
The Clinical Research Associate monitors clinical trials, maintains site integrity, ensures compliance, and resolves site issues while supporting investigators.
