Performs QA review and approval of documents data protocols and reports.
Performs QA audits and/or inspections preparing and distributing audit reports to the study director principal investigator and/or management in a timely manner.
With guidance reviews deviations and investigations.
Maintains accurate quality assurance files records and databases and may perform analysis and trending.
May assist in QA review of SOPs.
Assists with QA improvement initiatives.
Demonstrates behaviors and attitudes that are supportive of others in the department as well as the organization.
Demonstrates client focus by actions and follow-through.
Gathers clarification for a thorough understanding of assigned tasks including prioritization of tasks.
Assists with quality system continuous improvement where needed.
May provide training assistance for routine QA data review.