Teams at Parexel

Conducts clinical trial site monitoring and management, including source data verification, data quality oversight, issue resolution, safety reporting, site staff training, documentation maintenance, monitoring reports, and compliance with ICH/GCP, regulations, and client procedures. Collaborates with investigators, healthcare professionals, Clinical Trial Assistants, and internal teams to support site selection through study closeout.

Manages clinical trial sites from qualification and initiation through closeout. Responsibilities include monitoring site compliance with protocols, ICH-GCP, and regulations; resolving site issues; reviewing data quality and documentation; supporting recruitment; managing study supplies and payments; conducting site visits and training; maintaining CTMS and trial master file records; and ensuring audit and inspection readiness. Requires extensive travel, strong communication, problem-solving, organizational, and clinical research skills.

Coordinates clinical trial site activation and ongoing site support, including regulatory and ethics submissions, Investigator Initiation Packages, essential document management, TMF filing, study system updates, audit support, and communication with investigators and study teams. Ensures compliance with ICH-GCP, FDA, and local requirements while resolving site issues and supporting clinical trial documentation throughout the study lifecycle.