BSc, CCRA is the President of 2K Clinical Consulting, Inc. a niche provider that focuses on simplifying trial management by providing monitoring and co-monitoring 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 USFDA as a GMP FDA investigator and transitioned into the GCP industry working for Quintiles (CRO) and sponsor companies such as Johnson & Johnson, Berlex Laboratories (now Bayer), Galderma and others. She has held many positions over the years such as in-house CRA, Regional CRA, Sr. CRA and Independent CRA Consultant and has been involved in projects as a GCP Auditor and Trainer. She has diverse experience in therapeutic areas of Cardiovascular, CNS, Medical devices, InVitro diagnostics, Infectious Diseases, Gastroenterology, Endocrinology and Women’s Health. Mrs. Kiner is certified and an active member of ACRP (Association of Clinical Research Professionals).