Clinical research monitor vs study coordinator

Differences between clinical research monitor and study coordinator 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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Study coordinator example responsibilities.

• Manage and analyze EKG and sleep data collect from subjects in confidential database.
• Establish and maintain strong community partnerships to achieve HIV prevention objectives.
• Conduct consent discussions and other study procedures per protocol and CFR and GCP guidelines.
• Maintain strict patient confidentiality according to HIPPA regulations, GCP and ICH , 21 CFR and other regulatory documentation.
• Maintain accurate IRB, regulatory and study documentation to insure compliance with protocol and good clinical practice guidelines.
• Coordinate day-to-day study activities including data collection and statistical analysis, protocol development/implementation, IRB relations, and staff development.
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