Clinical Trial Label Compliance Associate

Job description

Location: Indianapolis, Indiana Pay Rate: $26.00/hour: The Clinical Trial Label Compliance Associate supports global clinical trial labeling by ensuring adherence to regulatory and quality system requirements. This role manages CAPAs, deviations, and change controls, and partners with labeling teams to investigate issues, identify root causes, and implement corrective actions. The associate helps maintain high quality standards and drives continuous improvement across labeling processes. Key Responsibilities: - Proactively track and monitor all Change and/or Deviation Management System and related compliance commitment activities/due dates for the Clinical Trial Labeling organization. Provide communication and follow up throughout the organization to help ensure on-time completion. - Maintain open lines of communication with management, customers, and vendors to relay critical issues and improve turn-around times for CAPA, deviations and changes. - Create and enter observation records and change controls into Change/Deviation Management System. • Work with Clinical Trial Labeling team members, including quality, to assist/support completion of deviations and changes that support im...