Description:
The purpose of the Quality Assurance (QA) Officer is to conduct the periodic, systematic, objective, and comprehensive examination of the total work effort to determine the level of compliance with Good Clinical Practice (GCP) standards.
The purpose of the Quality Control (QC) Officer is responsible for the day-to-day QC activities for the site with support from the clinical staff. He/she conducts the real time observation and documentation of the sites work processes to ensure that accepted procedures are followed.
Responsibilities:
QA Officer is responsible for reviewing at least 20% of participant files weekly, including source documentation and completed case report forms (CRFs).
They analyze QA findings, communicate them to staff, and ensure timely resolution of issues.
The officer uses tools like the Participant Chart Review and Issue Tracking Tool to identify trends, develop Corrective and Preventive Actions (CAPA) if needed, and monitor their effectiveness.
They prepare reports on trends for monthly meetings and conduct QA analysis every three months.
Additionally, they perform comprehensive QA for files during quarterly site monitoring visits, for the first five participants in new studies, and for new staff until competency is confirmed.
