Program Manager, Research Compliance & Quality Assurance

MultiCare Health System

4d•$108,680 - $156,354•Onsite

About The Position

The Program Manager, Research Compliance and Quality Assurance at MultiCare oversees clinical research compliance and quality assurance across multiple business units. The individual will support Principal Investigators and Clinical Research Coordinators in regulatory adherence; participates in audits; develops quality processes; and collaborates with clinic managers and leadership. The Program Manager will support predictive risk management with a focus on business enablement and value creation.

Requirements

Bachelor’s degree is required, preferably in a science or healthcare-related field
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

Nice To Haves

Graduate degree in business, healthcare management or related field preferred
CHRC (Certified in Healthcare Research Compliance) preferred
Three (3) years of experience in a managerial or supervisory capacity preferred

Responsibilities

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.