Kimberly Kiner, BSc, CCRA is the President of 2K Clinical Consulting, Inc. a niche provider that focuses on simplifying trial management by providing monitoring, co-monitoring, and auditing services to sponsor companies, CROs and sponsor-investigators. She has 13+ years of experience in the regulatory/ quality assurance and clinical research industry. She started her career at FDA as a GMP investigator specializing in Medical Devices. She later transitioned into the GCP industry working for CRO and sponsor companies and has held many positions over the years in CRA, auditor and other managerial roles. She has a diverse experience in therapeutic areas of Medical devices, InVitro diagnostics, Cardiovascular, CNS, Infectious Diseases, Gastroenterology, Endocrinology and Women’s Health.