Clinical research monitor vs senior clinical research associate

Differences between clinical research monitor and senior clinical research associate duties and responsibilities

Clinical research monitor example responsibilities.

• Manage a consultant to review scientific support and create dossiers on each product that make health claims in the EU.
• Maintain CTMS project tracking system of subject and site information and essential documents.
• Collect and review all initial regulatory documents from site for submission to IRB and sponsor.
• Coordinate and conduct the training of site personnel on protocols, CRF review and conduct source document verification.
• Resolve CRF discrepancies and/or clarifications via site visit, telephone, email or fax as deemed appropriate for the study.
• Prepare high quality site documents and collect country-specific information for IRB processes.
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Senior clinical research associate example responsibilities.

• Manage a consultant to review scientific support and create dossiers on each product that make health claims in the EU.
• Interact with FDA and other regulatory authorities to manage and facilitate approval of regulatory submissions.
• Monitor U.S. sites in accordance with ICH and GCP guidelines.
• Maintain investigators and subjects files, review investigators files for compliance with GCP and FDA regulations, review drug utilization records.
• Verify informed consent procedures and protocol requirements base on applicable regulatory requirements to ensure protection of study patients.
• Provide site management for both therapeutic and supportive care oncology protocols that are complex and require knowledge in advance therapeutic areas.
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