Kellie Thommes, RN, BSN, CCRP

Experience

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  US Air Force Wright Patterson Medical Center

  Feb 1996 - Feb 2000

  Charge Nurse, Intensive Care Unit

  Active duty Air Force charge nurse in general 12-20 bed adult intensive care units providing professional nursing care to the full gamut of adult medical and surgical patients, including post-op cardiovascular and neurological patients.

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  Indian Health Service Hospital

  Mar 2000 - Mar 2002

  Charge Nurse and Unit Manager

  Charge clinical nurse in four bed progressive care unit; acting hospital supervisor as needed. Floated to general medical floor, obstetrics and emergency rooms as needed.

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  US Food and Drug Administration

  Mar 2002 - now

  FDA Biomedical Research Consumer Safety Officer

  As an FDA Consumer Safety Officer I have conducted inspections spanning food, biologics (blood banks, plasma collection, human tissue), medical devices, and biomedical research (BIMO). In total I have performed over 350 inspections. In the BIMO program, my inspections have yielded Warning Letters to a Clinical Investigator (CI), a Medical Device Sponsor, and a Good Laboratory Practices (GLP) animal research facility. Since 2018, I have held the Certified Clinical Research Associate (CCRP) credential from the Society of Clinical Research Associates (SOCRA). In addition to the CI, GLP, and sponsor inspections, I also performed Post Marketing Adverse Drug Experience (PADE), Risk Evaluation and Mitigation Strategies (REMS), Institutional Review Boards (IRB), Clinical Bioequivalence-Bioavailability, and Remote Regulatory Assessments. Show less