In response to growing pressures from federal sponsors to demonstrate efficient research oversight, the Penn State College of Medicine undertook a strategic reorganization of clinical research monitoring and auditing services. This effort involved centralizing monitors from multiple units and realigning an auditor into our human research quality assurance office. A scalable chargeback model was developed to support this new structure, financial stewardship, and risk-based workload allocation. Attendees will learn how institutions can transition from siloed, grant-dependent quality functions to a centralized model that is both cost-recoverable and operationally sustainable. They will learn how to evaluate capacity, align oversight with risk profiles, and design a flexible fee structure based on study complexity and enrollment. The session explores how the reorganization positions the institution to adapt to the evolving expectations around indirect costs. This presentation provides a practical roadmap for modernizing research oversight by enhancing sustainability, or maximizing value from existing resources.

CEU: 1.00 ACRP

Speaker:

• Kevin Gardner, Jr., MS, BSN, RN, CCRC, Director, Clinical Trials Office, Penn State College of Medicine