Clinical Research Associate (West Coast)
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De functie
The Clinical Research Associate ensures high-quality monitoring of assigned protocols and sites in accordance with the study protocol, SOPs, GCP, and regulatory requirements.
Responsibilities include on-site and remote monitoring visits, site initiation, interim visits, and close-out visits with timely monitoring reports.
Create and maintain study-specific monitoring documentation, train site personnel, and ensure proper source documentation and case report completion.
Oversee regulatory documentation accuracy, support regulatory queries, and manage investigational supplies, dispensing, inventory, and reconciliation.
Monitor site enrollment, protocol deviations, SAEs, laboratory abnormalities, and other activities to ensure compliant trial conduct.
Coordinate with internal teams, sponsors, and external partners, participating in meetings and ensuring proactive communication and issue resolution.
Responsibilities include on-site and remote monitoring visits, site initiation, interim visits, and close-out visits with timely monitoring reports.
Create and maintain study-specific monitoring documentation, train site personnel, and ensure proper source documentation and case report completion.
Oversee regulatory documentation accuracy, support regulatory queries, and manage investigational supplies, dispensing, inventory, and reconciliation.
Monitor site enrollment, protocol deviations, SAEs, laboratory abnormalities, and other activities to ensure compliant trial conduct.
Coordinate with internal teams, sponsors, and external partners, participating in meetings and ensuring proactive communication and issue resolution.
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