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Inova Health Systems CLIN RESEARCH REGULATORY SPEC in FALLS CHURCH, Virginia

Job Description About Inova Inova is Northern Virginia’s leading nonprofit healthcare provider, recognized in 2019 and 2020 by U.S. News & World Report, which named Inova Fairfax Hospital the #1 hospital in the Washington, DC region. Each of Inova’s five hospitals holds a 5-star rating from the Centers for Medicare & Medicaid Services (CMS), distinguishing Inova as the highest-rated large health system in the U.S., and the only system to have all hospitals receive five stars. All five Inova hospitals were awarded ‘A’ grades for the spring 2020 Leapfrog Hospital Safety Grades, recognizing Inova’s achievements in protecting patients from harm and providing safer healthcare. Inova Fairfax Medical Campus was named to the Fortune/IBM Watson Health 100 Top Hospitals list, ranking in the top 10 nationwide among Major Teaching Hospitals. Our mission is to provide world-class healthcare – every time, every touch – to each person in every community we have the privilege to serve. Inova’s 18,000 team members serve more than 2 million individuals annually through an integrated network of hospitals, primary and specialty care practices, emergency and urgent care centers, outpatient services and destination institutes. Inova is home to Northern Virginia’s only Level 1 Trauma Center and Level 4 Neonatal Intensive Care Unit. Its hospitals have a total of 1,936 licensed beds. More information and statistics about Inova can be found at www.inova.org. _ _______________________ *Position Summary The Regulatory Specialist works to support the Inova Heart and Vascular Research. This position is responsible for all aspects of regulatory compliance for a large portfolio of clinical trials that include industry, NIH–sponsored and Principal investigators initiated clinical trials. This support includes the submission of protocols and amendments to the institutional review boards. Acts as the department’s representative and primary contact relative to regulatory affairs. Manages activities of regulatory affairs and the preparation, review, and submission of documents to the IRB, FDA, NIH, industry sponsors, and other academic centers. The Regulatory Specialist will assist the Principal Investigator and research coordinators in the data collection and submission of event reports including but not limited to non-compliance, adverse events, serious adverse events, unanticipated problems, and protocol deviations/violations. Participates in continuing review and renewal of SOPs. ## Requirements Experience * Two or more years of relevant research administrative/regulatory experience. Previous experience working with a University and /or federal, state or local regulatory authorities. * Previous internal experience preferred. Demonstrated ability to conceptualize, manage, prioritize and complete complex concurrent projects. _Education_ * BS/BA or 5 years of relevant research experience * Master's degree preferred Our commitment to keeping patients safe, means there’s no safer place for you to work. We safeguard our patients, by safeguarding our team members. * Inova is well stocked with the best and latest PPE * Masks are provided to patients entering our buildings, and offered free to visitors * Covid-19 patients are isolated in dedicated areas * Inova operates curbside Covid-19 testing sites that are far removed from the main facilities * All team members are trained in the latest screening guidelines #LI-SM1 *Work Site Location: INOVA FAIRFAX MEDICAL CAMPUS Work Site Address: 3300 GALLOWS ROAD Schedule: Monday-Friday Work Site City/State: FALLS CHURCH, VA Shift: Day
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