Program Manager, Research Compliance

Job Summary

Overseeing clinical research compliance and quality assurance in a full-time remote capacity, the Program Manager, Research Compliance will support Principal Investigators and Clinical Research Coordinators in regulatory adherence, participate in audits, and develop quality processes while collaborating with clinic managers and leadership.

Key responsibilities:

• Supports Principal Investigators (PIs) and Clinical Research Coordinators (CRCs) in conducting research in compliance with CMS and FDA regulations
• Participates in clinical research audits, providing expertise on organizational policies
• Develops and implements processes to enhance quality and ensure compliance with regulatory agencies

Required qualifications:

• Bachelor's degree in a science or healthcare-related field is required
• Graduate degree in business, healthcare management, or a related field preferred
• CHRC (Certified in Healthcare Research Compliance) preferred
• Minimum of six years of experience in a clinical research environment focused on regulatory compliance
• Good Clinical Practice (GCP) certification required or to be obtained within six months of hire