Karen Denise Williams

Karen Denise Williams is an experienced Clinical Records Specialist I at United Therapeutics Corporation since June 2016, with a strong background in managing Trial Master Files (TMF) and supporting clinical trial activities in compliance with regulatory standards. Previously held positions include Lead Clinical Records Coordinator, Senior Clinical Trials Administrator-TMF Support Analyst, and In-House CRA at PRA Health Sciences, demonstrating proficiency in essential document collection, site management, and CRO oversight. Karen has also worked with organizations such as Chiltern, Premier Research, and Salix Pharmaceuticals, focusing on regulatory file maintenance, study start-up, and quality control. Educational credentials were obtained from Durham Technical Community College in 2014-2015 and 2001-2002.