Program Manager, Research Compliance & Quality Assurance

• Supports Principal Investigator (PIs) and Clinical Research Coordinators (CRCs) across the organization in conducting research and clinical trials in compliance with CMS and FDA regulations and ICH E6 (R3) Good Clinical Practice standards.
• Supports PIs and CRCs and other research team members in remaining compliant with internal MultiCare policies on conducting research in the clinical environment.
• Participates in all clinical research audits, supporting the research team and providing organizational policy expertise.
• Develops and implements processes to enhance quality and assure compliance with regulatory agencies for all clinical research performed within MultiCare.
• Collaborates with clinic managers to provide leadership and guidance to clinical research staff, fostering a culture of continuous improvement and professional development.
• Interprets and integrates organizational policies into clinical research workflows to ensure seamless administrative and clinical operations.
• Partners with leadership and Research Administration team to analyze operational data to identify areas for improvement.

Requirements:

• Bachelor’s degree is required, preferably in a science or healthcare-related field
• Graduate degree in business, healthcare management or related field preferred
• CHRC (Certified in Healthcare Research Compliance) preferred
• Familiarity with ICH E6(R2 & R3) Guidelines for Good Clinical Practice
• Good Clinical Practice (GCP) certification required or obtained within 6 months of date of hire
• Minimum of six (6) years of experience in a clinical research environment, with emphasis on regulatory compliance and/or clinical conduct
• Three (3) years of experience in a managerial or supervisory capacity preferred