Title/s: Chief Compliance Officer, Emory University
Kristin Hamernik West is the Chief Compliance Officer for Emory University. She oversees Emory’s overall compliance program, which encompasses research and administrative areas. Her experience includes developing and implementing risk analysis tools, developing an annual compliance plan based on risk assessment results, reviewing and interpreting governing laws and regulations, Developing corrective and preventative action plans (CAPA) and corresponding monitoring plans to evaluate CAPA success, and providing legal advice to regulatory oversight committees such as the Institutional Review Board, the Institutional Animal Care and Use Committee and Institutional Biosafety Committee. She also serves as the University Privacy Officer and Research Integrity Official. Prior to working at Emory University, Kristin was a Federal Prosecutor for the United States Department of Justice, Antitrust Division where she conducted investigations into and prosecution of violations of federal antirust laws.
Kristin is a certified as a Health Care Research Compliance Officer by the Health Care Compliance Association. An expert in research compliance, she has been invited to give numerous presentations on research compliance issues involving electronic health records and big data, the Sunshine Act, research integrity, research compliance risk assessments, clinical trials, and informed consent. She has also been published in the Research Compliance Professional’s Handbook, 2nd Edition.
MS Pharmaceutical Outcomes & Policy, Drug Regulatory Affairs, University of Florida, College of Pharmacy
JD magna cum laude, Mercer University Law School
BA summa cum laude, University of Maryland