The Regulatory Specialist works to support the Infectious Diseases Clinical Trial Unit at Georgetown University.  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.