not “professional trainers” who simply read slides to you and have never actually
completed the work they are teaching.
- Are highly
knowledgeable clinical research trial professionals who have extensive training experience.
actively involved in the clinical research industry as auditors, consultants, investigators,
speakers and writers.
Tamera Norton Smith, PhD, MT(ASCP), President, Senior
Ms. Smith is a former award-winning FDA investigator who is an active auditor, consultant,
author and trainer throughout the pharmaceutical and medical device industries. Her more
than 22 years’ experience in the clinical research industry has included inspecting IRBs,
CROs, Sponsors and Clinical Investigators, consulting, monitoring clinical trials and
performing sponsor audits. Ms. Smith provides clinical research training in several areas,
including fraud detection and prevention. Through her extensive experience in pursuing suspect data
cases, she has developed a unique skill-based program for detection and prevention of clinical
research fraud and misconduct. With more than 15 years of teaching experience, Ms. Smith brings an
unparalleled level of energy and enthusiasm for her subject matter.
- National and Regional Speaker for Association of Clinical Research Practices (ACRP)
- Speaker for Canadian and other North American Research Conferences
- Awarded for FDA casework related to Good Clinical Practices and Good Manufacturing
- Nationally recognized by the U.S. Department of Health and Human Services for her work in
biologics and GMP fraud detection
- Accomplished the first anti-tampering prosecution in the southeast United States
- Selected to train the FDA’s Center for Devices and Radiological Health Division, 2004 and 2005,
regarding current industry practices
- Achieved one of three cases necessary to support the nation's first National Blood Bank Consent
- Sponsored the First Joint White Collar Crime Symposium for Clinical Research Professionals,