Job Summary:

In addition to the responsibilities listed below, this position is also responsible for beginning to ensure that research team members are working in compliance with state, federal, and institutional regulatory requirements (e.g., Food and Drug Administration (FDA) regulations, National Institute of Health guidelines, human research protection); beginning to develop and train on-site procedures pertinent to regulatory compliance in consultation with site staff; preparing components of Institutional Review Board (IRB) and/or FDA documents with some guidance; supporting the preparation and maintenance of study-related regulatory documents (e.g., protocol and consent forms, brochures, events documentation, compassionate use application); supporting regulatory quality assurance activities for the department; assisting in the preparation for internal and external inspections and audits; maintaining and/or supporting the development of policies and procedures for new gui...