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Clinical Quality Assurance Officer

Job Summary

Responsible for ensuring clinical processes are conducted in accordance with guidelines and regulations. Develops, performs, and manages quality assurance activities. Presides over audits.

Primary Responsibilities

  • Ensure that all processes contributing to the performance of a clinical trial are conducted properly.
  • Troubleshoot clinical trials and activities.
  • Manage and maintain databases for the quality system.
  • Prepare and assist in preparing annual reports and quality trending reports.
  • Report the status of the quality levels of staff, systems and production activities.
  • Preside over improvement programs.
  • Evaluate quality events, incidents, queries, and complaints.
  • Keep up to date with all related quality legislation and compliance issues
  • Compile and prepare materials for submission to regulatory agencies.
  • Document internal regulatory processes.
  • Ensure regulatory rules are communicated through corporate policies and procedures.
  • Utilize guidance documents, international standards, or consensus standards and interpret for guidance.
  • Ensure that investigator, vendor, facility and system audits are conducted.
  • Communicate any critical compliance risks noted from these activities to senior management.
  • Assume a lead role for the preparation, conduct, and responses to regulatory agency.
  • Provide leadership and strategy in line with global strategic objectives.