Karen S. Sargent is a Quality Compliance Auditor and Director of Training at Polaris Compliance Consultants, Inc. With 30 years experience in clinical research from the perspectives of the Investigative Site, Sponsor, and Contract Research Organization (CRO), Karen has extensive experience in the pharmaceutical and medical device industries. She has performed countless global quality audits for pharmaceutical and medical device sponsors, clinical sites, institutional review boards, and performed vendor qualification assessments. In addition to FDA/ICH audits, Karen has been a trainer throughout her career and brings a global perspective to classroom discussions. Karen offers first-hand accounts of numerous case studies during each training session. She has trained countless numbers of Clinical Investigators, Clinical Research Coordinators (CRC), Research Site Directors and Clinical Research Associates (CRA) for numerous organizations. Karen has designed and authored clinical research training manuals for pharmaceutical and medical device companies and site management organizations and she designed an in-depth computer-based CRA qualification assessment tool for a CRO.