Resume of a senior clinical research coordinator with no apparent links to high‑level political or financial misconduct

e Created a career track for Clinical Research Coordinators including ACRP certification opportunities and a centralized pool of research coordinators to promote steady workflow. e Commissioned an audit of 10% of all active human subject trials for compliance to good clinical practice (GCP). Collaborated with Institutional Review Board (IRB) Chair when remediation was necessary. Sat on the IRB. e Invited by Dr. Barry Coller, Chairman of Medicine to join the Patient Oriented Research Committee. Senior Research Coordinator, Division of Infectious Diseases (1993-1997) Collaborated with the Hospital Epidemiologist as Senior Research Coordinator on a CDC multicenter study to measure the effects of using safety devices to draw blood, start IV’s and give injections to determine if they decreased needle sticks in healthcare workers. The device companies (Johnson and Johnson, Becton Dickenson and Vacupro) extended the study solely at The Mount Sinai Hospital. This research opened the multi-billion dollar market for safety devices. e Hired study personnel. Arranged with Procurement to cancel contracts to remove non-study devices from the institution. e Inserviced 3000 nurses and physicians on the use of the study devices. e Audited sterilized used “sharps boxes” to assess implementation rates of the study devices. e Included as a co-author of an article in Morbidity and Mortality Weekly Report. Cornell University Medical College, New York, N.Y. (1986-1993) Department of Child Development, Research Nurse Coordinator Coordinated a National Institute of Mental Health funded pediatric study. Recruited subjects, developed tools to achieve stated research goals, implemented research protocols, analyzed data and prepared reports. Department of Surgery Research Nurse Specialist Established initial infrastructure and managed a multi-site surgical metabolism laboratory consisting of 4 full-time surgical fellows with an annual budget of $800,000. The study data and collaboration with Dr. Anthony Cerami’s laboratory at Rockefeller University supported Dr. Kevin Tracy’s seminal work on tumor necrosis factor (TNF). Implemented federally funded research protocols. Procured and managed supplies. Recruited control subjects and hospitalized inpatient subjects and obtained informed consent. e Assisted physician researchers with all clinical and laboratory aspects of the study including processing, cataloging, transporting and storing specimens. e Carried out study protocols for ICU inpatient and outpatient human subjects. e Prepared submissions for IRB approval to assure patient safety and regulatory compliance. Critical Care Registered Nurse, New York, N.Y. (1988-1997) Neonatal ICU nurse at Mount Sinai, New York Hospital, Lenox Hill Hospital, Columbia-Presbyterian Hospital, contracted through a hospital staffing agency. New York Hospital, New York, N.Y. (1979-1988) Registered Nurse, Neonatal ICU. Delivered care to critically ill infants. Supervised ancillary personnel, assigned nursing staff, maintained detailed written records and electronic medical records for all patients. EDUCATION University of Massachusetts, Amherst, Massachusetts. M.S. Exercise Physiology, Cum Laude, 1987. University of Florida, Gainesville, Florida. B.S. Nursing, Cum Laude, 1979. HOUSE_OVERSIGHT_015674