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.
Bachelor’s Degree required; Master’s Preferred. 3+ years experience in clinical trial drug regulatory support and management of regulatory documents for multiple PI’s. The incumbent must have proven track record of regulatory experience at an academic medical center or hospital.
Telecommuting is allowed.
About Georgetown University
Georgetown University is one of the world’s leading academic and research institutions, offering a unique educational experience that prepares the next generation of global citizens to lead and make a difference in the world. We are a vibrant community of exceptional students, faculty, alumni and professionals dedicated to real-world applications of our research, scholarship, faith and service.
Established in 1789, Georgetown is the nation’s oldest Catholic and Jesuit University. Drawing upon the 450-year-old legacy of Jesuit education, we provide students with a world-class learning experience focused on educating the whole person through exposure to different faiths, cultures and beliefs. Students are challenged to engage in the world and become men and women in the service of others, especially the most vulnerable and disadvantaged members of the community.
These values are at the core of Georgetown’s identity, binding members of the community across diverse backgrounds.