Clinical quality assurance associate vs senior clinical research associate

Differences between clinical quality assurance associate and senior clinical research associate duties and responsibilities

Clinical quality assurance associate example responsibilities.

• Manage complex development programs consisting of multiple geographically separate teams supporting automation, regression, feature test and system test.
• Conduct audits for GCP, GLP and GMP facilities.
• Prepare internal study teams and provide support for FDA BIMO sponsor inspections.
• Assess compliance of Sponsor/Investigator/Monitor/Vendor activities to the study protocol, ICH GCP guidelines and all applicable regulations.
• Implement a full blown internet base CAPA system that allow internal and external customers to efficiently communicate need improvements.
• Assist in the resolution and approval for CAPA identify issues on sterilization and environmental microbial controls and implementing proactive programs.
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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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