Karen Ulisney is a Policy Analyst in the Clinical Trials Program, Office of Device Evaluation (ODE), Center for Devices and Radiological Health (CDRH) at FDA. She is an Adult Nurse Practitioner by training and her work at FDA is focused on regulatory review for good clinical trial practice and human subject protections and a member of the CDRH Real World Evidence implementation team.  Karen has also worked as a Lead Reviewer in ODE/Division of CV Devices and the Clinical Trials Lead in the Division of Bioresearch Monitoring (BIMO). Prior to joining FDA in 2011, Karen was a Clinical Trials Specialist at NIH/National Heart and Lung Institute and responsible for managing clinical trials grant and contract portfolios and a research coordinator at the NIH Clinical Center.