The Regulatory specialist will be responsible for the execution, management and oversight of all regulatory requirements and affairs for the Department of OB-GYN portfolio including retrospective and prospective research protocols and clinical trials involving human subjects and animals performed by or in collaboration with the Department of OB-GYN. Activities and responsibilities range from protocol and clinical trial development, submissions, approvals, amendments, continuing reviews, annual renewals, closures, terminations and reporting requirements for primary, secondary and administrative Institutional Review Boards (IRBs) or Institutional Animal Care and Use Committee (IACUC) of record, as well as the Henry M. Jackson Foundation (HJF), U.S. Food and Drug Administration (FDA), U.S. Department of Health and Human Services (DHHS), Department of Defense (DOD)\. The Regulatory specialist will temporarily serve as the point of contact for the Department of OB-GYN with local IRBs and IACUCs, the Office of Research Protection (ORP) and the Animal Care and Use Review Office for USAMRMC at Fort Detrick, and the Regulatory Affairs Department at HJF. The Regulatory specialist will be required to manage and expand the tracking system for protocols, regulatory binders, and a record of communications, activities and documentation for the OB-GYN portfolio; to ensure that regulatory approvals are current and that staff maintains current CITI training for research involving human subjects. The Regulatory specialist will also coordinates Compliance, Contracting and Protocol Management responsibilities for the Dept of OB-GYN as needed
Internal Number: 38408BR
About Inova Health System
Inova is a global leader in personalized health, which leverages precision medicine to predict, prevent and treat disease, enabling individuals to live longer, healthier lives. At Inova, we serve more than two million people each year from throughout the Washington, DC, metro area and beyond. Inova's mission is to improve the health of the diverse community it serves through excellence in patient care, education and research. At Inova, more than 16,000 employees demonstrate their commitment every day to providing the community with expert, world-class, compassionate patient care.