Regulatory Support & Advocacy Core Personnel
Terry Vanden Hoek, MD, Core Director
Dr. Vanden Hoek directs the Regulatory Knowledge and Support Core. Since, 2010, Dr. Vanden Hoek he has served as the Professor & Head, Department of Emergency Medicine, University of Illinois at Chicago. Dr. Vanden Hoek has 20-years of experience in translational science partnerships, team and career building, as well as complex research project development that integrates relevant regulatory knowledge. He focusses on mentoring and building a department faculty and training program committed to diversity and improving the health of underserved communities and at-risk individuals. Several new initiatives have required navigation of regulatory rules within the health system and engagement with the IRB, partnering hospitals and emergency medical systems as well as Chicago and Illinois communities. NIH, PCORI and foundation funding support efforts to use the emergency department as a platform for cardiac risk screening and FQHC transitional care planning for improved hypertension management (faculty PI: Heather Prendergast), HIV screening of at-risk individuals identified by zip code for follow up and treatment at community clinics (faculty PI: Janet Lin) and a multi-hospital collaborative for patient-centered development of family asthma action planning for pediatric patients identified in the emergency department. . He has also worked with national leaders to publish recommendations about implementing regulations about exception from informed consent.
Lynn Podraza, MS, Director, Research Navigation
Ms. Podraza is the Director of Research Navigation Services for the Center for Clinical and Translational Science (CCTS) at the University of Illinois at Chicago (UIC) where she advises UIC clinical and translational research investigators and study coordinators. The Research Navigator provides consultative services and assistance to investigators and their research teams trying to meet regulatory requirements for all types of IRB submissions, best practices for FDA IND submissions, and designs training programs that promote research ethics and professional development for research personnel.
Ms. Podraza spent more than 25 years in the pharmaceutical industry. She reviewed and developed research protocols, and planned and implemented clinical trials. Ms. Podraza was responsible for evaluating potential investigators and research sites, selecting and managing contract research organizations, and negotiating contracts and managing clinical research trials. She wrote, reviewed and approved research protocols, clinical study reports, annual IND updates to the FDA, manuscripts and other publications. She developed and managed a best practices training program and managed quality assurance (QA) projects. She also consulted on QA process development and training.