Clinical trials associate vs research nurse

Differences between clinical trials associate and research nurse duties and responsibilities

Clinical trials associate example responsibilities.

• Manage trial master files and study document to meet GCP/ICH and internal guidelines for records retention.
• Audit TMF to ensure all require regulatory documentation are collected and lead.
• Work closely with investigators to recruit eligible patients to clinical protocols, manage data collection and preparation.
• Preform ICF customization in accordance with ICH guidelines, GCP s and local regulatory requirements.
• Support the setup, data entry and QC of the system to ensure accuracy and quality of data.
• Monitor clinical data and resolve inconsistencies according to FDA regulations and ICF guidelines.
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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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