Clinical quality assurance associate vs research coordinator

Differences between clinical quality assurance associate and research coordinator 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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Research coordinator example responsibilities.

• Manage participant's records ensuring confidentiality as well as NIH specifications.
• Manage all IRB submissions, sponsor communications, participate in monitoring visits, drug reconciliation and dispensing.
• Recruit, screen, conduct psychometric examinations and collect data for pharmaceutical clinical trials in patients diagnose with Alzheimer's disease.
• Maintain confidential information and appropriate ethical professionalism with highly sensitive personal health information; take part in IRB human subjects training.
• Assist in preparation of grants, NIH progress reports, presentations, and manuscripts.
• Ensure and maintain confidentiality, privacy and compliance of patient rights in accordance with HIPAA regulations and NVCI policies.
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