Senior clinical research associate vs research nurse

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

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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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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