Clinical quality assurance associate vs clinical research associate

Differences between clinical quality assurance associate and 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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Clinical research associate example responsibilities.

• Manage, schedule and train up to 15 CRAs.
• Recruit patients, attain patient inform consent form, educate subjects on compliance, and ensure patient safety per ICH guidelines.
• Manage site TMF to ensure communication requirements adherence
• Manage CRO and regional monitor to complete close out activities, including device accountability management.
• Manage regional academic and community base oncology practices as the primary contact for all communications and support.
• Manage the monitoring CRO and the data clean-up efforts for a 510k submission and interim/annual study reports by effectively collaborating cross-functionally.
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