CRA 2, Internal Medicine, Biotech
仕事内容
Conduct site visits including site selection, initiation, monitoring, and close-out to ensure trials are executed per protocol.
Ensure ongoing trial conduct aligns with GCP, ICH guidelines, and sponsor requirements.
Coordinate communications with site staff, resolve queries, and manage issue escalation.
Verify source data, maintain essential regulatory documents, and support regulatory submissions as needed.
Collaborate with cross-functional teams to uphold data quality and patient safety.
Identify risks, implement corrective actions, and contribute to trial timelines and milestones.
Ensure ongoing trial conduct aligns with GCP, ICH guidelines, and sponsor requirements.
Coordinate communications with site staff, resolve queries, and manage issue escalation.
Verify source data, maintain essential regulatory documents, and support regulatory submissions as needed.
Collaborate with cross-functional teams to uphold data quality and patient safety.
Identify risks, implement corrective actions, and contribute to trial timelines and milestones.
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