Outsourcing in Clinical Trials – Southern California

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Nancy is a Registered Nurse with over 25 years of experience at Duke University Medical Center. For 11 of those years, she was a critical care transport nurse for the helicopter and ground ambulance program, and for 14 years she provided senior operational leadership for global multi-center clinical trials and registries, including direct responsibility for regulatory compliance, and strategic development of Project Management, Site Management, and Clinical Monitoring services at the Duke Clinical Research Institute (DCRI). Nancy is experienced in managing multiple therapeutic business units including the development and operational oversight of the cardiovascular therapeutic area. Nancy joined the Worldwide team in July 2010 and has provided operational oversight and leadership for Cardio-metabolic projects.

Toni spent 10 years in academia as a clinical cardiologist at St. Louis University followed by University of Minnesota. Her subspecialty being cardiac imaging, she spent several years performing industry sponsored research in ultrasound microbubble imaging at St. Louis University and investigator-initiated research at University of Minnesota. She was a fixture in the cardiology clinics as well and was noted as one of the top cardiologists in St. Louis in 2000. In 2006 she left academics to work in the pharmaceutical industry, primarily big pharma where she has worked for 10 years (Schering Plough, Novartis). She has worked for Worldwide Clinical Trials since August, 2015 in the cardiovascular therapeutic area as a medical monitor.

Karen joined Worldwide in 1993 and is responsible for Global Project Management within the Cardiovascular and Late Phase division. Karen Hill has more than 22 years of experience in the CRO industry and has worked on numerous large cardiovascular outcome studies conducted by the group including; INJECT, GUSTO III, InTIME-II-TIMI 17, OPUS-TIMI 16, PROVE IT–TIMI 22, CLARITY–TIMI 28, MERLIN-TIMI 36, where she held the position of Global Project Manager/Director. In 2003, Karen took over as head of the Project Management department, which included the management and supervision of the companies’ project managers, CRAs and the IVRS development and support teams. Karen currently heads up the Global Cardiovascular Project Management division at WCT and continued to supervise a global team working on both large cardiovascular outcome studies, as well as other phase II-IV studies in other cardiovascular indications.

Karen joined Worldwide in 1993 and is responsible for Global Project Management within the Cardiovascular and Late Phase division. Karen Hill has more than 22 years of experience in the CRO industry and has worked on numerous large cardiovascular outcome studies conducted by the group including; INJECT, GUSTO III, InTIME-II-TIMI 17, OPUS-TIMI 16, PROVE IT–TIMI 22, CLARITY–TIMI 28, MERLIN-TIMI 36, where she held the position of Global Project Manager/Director. In 2003, Karen took over as head of the Project Management department, which included the management and supervision of the companies’ project managers, CRAs and the IVRS development and support teams. Karen currently heads up the Global Cardiovascular Project Management division at WCT and continued to supervise a global team working on both large cardiovascular outcome studies, as well as other phase II-IV studies in other cardiovascular indications.

Dr. Khalifa has more than 20 years of experience in clinical research and drug development in the pharmaceutical and biotechnology industries. He has managed several clinical programs from inception in multiple therapeutic areas including inflammation, neuro-immunology, neurology, endocrinology, cardiovascular, urology, women's health, respiratory disorders, rare diseases, and oncology. Throughout his career, Dr. Khalifa has been responsible for the submission and approval of 11 NDAs (New Drug Applications). Prior to his work in the pharmaceutical industry, Jim was in clinical practice in New Jersey and New York. He was trained in Internal Medicine and Neurology at Linden Medical Center in New Jersey and is Internal Medicine Board Eligible. Jim received his Medical Degree from Alexandria University, Egypt and continued his medical education at Harvard Medical School. He also received his EMBA from the University of Science in Philadelphia.