Key responsibilities include facilitating completion of initial essential regulatory documents (FDA 1572, Financial Disclosure forms, PI signature pages, etc), creating/organizing regulatory binder and/or electronic files for new studies and maintaining regulatory binder and/or electronic files throughout the course of the study, filing/updating all required documents and ongoing training/certifications appropriately, overseeing training logs and delegation of duties logs, working with study coordinator to ensure completion prior to enrollment and ongoing accurate maintenance throughout the study, maintaining documentation of all relevant training, preparing for and managing regulatory portion of industry study monitor visits, addressing all regulatory action items, creating informed consent documents for new studies and updating informed consent documents as needed throughout the study, facilitating process for investigator receipt and evaluation of external IND safety reports, and other duties as assigned. Qualifications: minimum qualifications: entry level: a bachelor's degree in public health, public administration, social/behavioral sciences, physical sciences, nursing, healthcare, or a directly related field from an accredited institution, intermediate level: a bachelor's degree in public health, public administration, social/behavioral sciences, physical sciences, nursing, healthcare, or a directly related field from an accredited institution 1 year professional experience in a clinical research setting with regulatory responsibilities, senior level: a bachelor's degree in public health, public administration, social/behavioral sciences, physical sciences, nursing, healthcare, or a directly related field from an accredited institution 2 years professional experience in a clinical research setting with regulatory responsibilities.