Karen Arata

Associate Director, Safety

In her role as Associate Director of Drug and Device Safety for Aperio, Karen provides oversight and management of all aspects of Safety Reporting for our sponsors’ clinical trials.

Karen has over 14 years of safety experience working from both the perspective of the sponsor and CRO. She can anticipate what is required and understands the need for the highest-quality safety deliverables. Karen has worked through multiple phases of clinical studies, from early phase through post-marketing safety, in both drugs and devices and across a myriad of therapeutic areas. She is adept at processing cases, regulatory reporting and utilizing safety databases. Karen is not only highly experienced, she has a nursing background which allows her to understand and apply the medicine inherent in safety reporting.

When she’s not busy ensuring the safety of clinical trial participants, Karen heads to the mountains of North Carolina to enjoy hiking, biking and many other outdoor activities along with investing time in her favorite charity – Friends of the Blue Ridge Parkway.