Clinical research monitor vs clinical research associate

Differences between clinical research monitor and 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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Clinical research associate example responsibilities.

• Manage, schedule and train up to 15 CRAs.
• Recruit patients, attain patient inform consent form, educate subjects on compliance, and ensure patient safety per ICH guidelines.
• Manage site TMF to ensure communication requirements adherence
• Manage CRO and regional monitor to complete close out activities, including device accountability management.
• Manage regional academic and community base oncology practices as the primary contact for all communications and support.
• Manage the monitoring CRO and the data clean-up efforts for a 510k submission and interim/annual study reports by effectively collaborating cross-functionally.
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