Clinical research monitor vs research nurse

Differences between clinical research monitor and research nurse 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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Research nurse example responsibilities.

• Collect, manage and analyze preliminary data using SPSS statistical software.
• Adhere to local and country specific GCP and ICH guidelines.
• Ensure coordinator and investigator compliance with GCP and ICH guidelines.
• Assure compliance with good clinical practice (GCP) guidelines and FDA regulations.
• Ensure appropriate source documentation, drug accountability and study compliance according to GCP and CFR.
• Oversee study protocol implementation to ensure compliance with FDA and other regulatory bodies' rules and regulations.
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