Clinical quality assurance associate vs clinical coordinator

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

• Manage chronic illnesses such as hypertension, coronary disease and diabetes.
• Create and manage case report forms and transmit data through EDC to sponsor.
• Manage patient telemetries systems to include EKG's, vitals, INR management and sleep monitoring systems.
• Manage the CRA team and serve as main point of contact for study logistics and relate questions including subject eligibility questions.
• Manage common side effects of chemotherapy and experimental therapies.
• Manage the clinical reimbursement coordinators traveling schedule to ensure that facilities have adequate MDS coverage.
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