Sr Cra - Canada (Quebec/Montreal)

SR CRA – Canada (Quebec/Montreal). Responsible for monitoring clinical studies, ensuring compliance with regulatory standards and supporting site operations throughout the study lifecycle.

Job Responsibilities

• Perform site qualification, initiation, interim monitoring, site management, and close-out visits (on-site or remotely).
• Use judgment to evaluate overall site performance and staff, providing recommendations and escalating serious issues.
• Maintain up-to-date knowledge of ICH/GCP Guidelines, regulations, and company SOPs.
• Verify informed consent processes, protect confidentiality, and assess factors affecting subject safety and data integrity.
• Conduct source document review, verify CRF data accuracy, and resolve queries within agreed timelines.
• Utilize hardware and software for data review and capture; ensure compliance with electronic data capture requirements.
• Perform IP inventory, reconciliation, a...