Clinical Research Regulatory Coordinator II

Position Summary The Clinical Research Regulatory Coordinator II will prepare, submit, and assist with multiple levels of clinical research documentation for the Neurology Research Unit. General Responsibilities To prepare, submit, and assist with multiple levels of research documentation (i.e. IRB submissions, educational materials, reports, grant renewal reports, and study forms). To maintain regulatory documentation including consent forms, protocols, 1572s, CVs, licenses, investigator brochures, recruitment materials, safety reports, and submission forms. To draft informed consents. To prepare and maintain FDA applications for Investigational New Drugs (INDs) and Investigational Device Exemptions (IDEs). To assist in drafting compliant advertisements. To serve as resource person or act as consultant within area of regulatory expertise. Perform other duties as assigned. Annual Salary Range - $47,665 - $77,455 Qualifications Bachelor's degree in a related field and three (3) years of related experience required. Work experience may substitute for education requirement. Preferred Qualifications Ideal candidate will have experience with exempt, expedited, and convened IRB submissions.