Regulatory Coordinator

Regulatory CoordinatorGeorgetown University comprises two unique campuses in the nation's capital. With the Hilltop Campus located in the heart of the historic Georgetown neighborhood, and the Capitol Campus, just minutes from the U.S. Capitol and U.S. Supreme Court, Georgetown University offers rigorous academic programs, a global perspective, and unparalleled opportunities to engage with Washington, D.C. Our community is a close-knit group of remarkable individuals driven by intellectual inquiry, a commitment to social justice, and a shared dedication to making a difference in the world.Job OverviewThe Regulatory Coordinator plays a critical role in ensuring regulatory compliance and oversight of a portfolio of clinical trials overseen by the Clinical Research Organization (CRO) at Georgetown University Medical Center (GUMC). Working under the direct supervision of the Director of the CRO, the CRC will manage regulatory for complex clinical trials across multiple studies and therapeutic areas. The CRO supports research efforts for various clinical departments within GUMC, and the Regulatory Coordinator plays a critical role in ensuring that all trials are conducted in strict accordance with study protocols, regulatory requirements, institutional policies, and Good Clinical Practice (GCP) guidelines. Additional duties include but are not limited to:Prepare and submit required regulatory documents (e.g., IRB applications, amendments, safety reports)Maintain accurate and up-to-date regulatory files for clinical research studiesEnsure compliance with institutional, federal, and sponsor regulationsCommunicate with investigators, study staff, and regulatory agencies to support study approvals and updatesWork InteractionsThis position reports directly to the Director of the Clinical Research Organization (CRO), who in turn reports to the Vice President for Biomedical Graduate Education and Research. The Regulatory Coordinator collaborates closely with a wide range of stakeholders across the clinical research enterprise. This includes daily interaction with principal investigators, study coordinators, data managers, and clinical trial sponsors. The role also requires frequent communication with the Institutional Review Board (IRB) and compliance offices. The Regulatory Coordinator often serves as the primary point of contact for regulatory correspondence and plays a key role in facilitating study start-up and ongoing regulatory maintenance. Strong interpersonal skills are essential, as the position involves navigating complex regulatory requirements while supporting diverse research teams and maintaining positive, professional relationships throughout GUMC.Requirements and QualificationsBachelor's degree in a health science, life science, or related fieldMinimum of 2 years of experience in regulatory affairs or clinical researchFamiliarity with regulatory and ethical requirements related to human subjects research (e.g., IRB, FDA, ICH-GCP)Strong attention to detail and organizational skillsExcellent written and verbal communication.Ability to manage multiple priorities and meet deadlinesCritical thinking and problem-solving abilities.Proficiency in Microsoft Office and familiarity with regulatory databasesPreferred Requirements and QualificationsMaster's degree or regulatory certification (e.g., SOCRA, ACRP)Experience working in an academic medical center or large research institutionKnowledge of electronic regulatory systems and clinical trial management systems (e.g., OnCore, REDCap)Work Mode DesignationThis position has been designated as On-Campus. Please note that work mode designations are regularly reviewed in order to meet the evolving needs of the University. Such review may necessitate a change to a position's mode of work designation. Complete details about Georgetown University's mode of work designations for staff positions can be found on the Department of Human Resources website.Pay Range: The projected salary or hourly pay range for this position which represents the full range of anticipated compensation is: $47,586.00 - $87,558.13 Compensation is determined by a number of factors including, but not limited to, the candidate's individual qualifications, experience, education, skills, and certifications, as well as the University's business needs and external factors.