Ashley Kuniholm graduated from Boston University with a BS in Human Physiology. She was an IRB administrator at Boston Children's Hospital for seven years before transitioning to the BCH Clinical Research Operations Center as a clinical research project manager. Ashley now serves as the Hospital's Regulatory Affairs Manager, assisting investigators across the Hospital with their FDA-regulated research, regulatory strategy for product development, and providing regulatory education to the BCH Research Community. She is also an active members of the N=1 Collaborative, as a member of the Operations Committee and the Data Coordination and Institutional Implementation workgroups.