Regulatory Coordinator, Heart & Vascular Institute, Full Time, Variable

Inspire health. Serve with compassion. Be the difference.Job SummaryPrepares, submits, and/or assists with multiple levels of research documentation (i.e., Institutional Review Board submissions, educational materials, reports, and study forms). Participates in planning and project management of new and ongoing studies. Serves as a resource person or acts as a consultant within the area of clinical research regulatory expertise.Essential FunctionsAll team members are expected to be knowledgeable and compliant with Prisma Health's purpose: Inspire health. Serve with compassion. Be the difference.In accordance with local, federal and study-specific requirements, prepares, coordinates and oversees the regulatory requirements for research performed within the department. Includes timely submission of phases of research regulatory documentation to local and external committees. Provides support to physicians and staff when coordinating efforts between faculty and educational institutions involved in collaborative research. Prepares regulatory documents for internal audits, sponsor monitoring visits or audits, or Food and Drug (FDA) audits. Acts as the subject matter expert during audits. Leads Quality Improvement initiatives related to regulatory compliance. Coordinates and maintains training records. Educates the research team on regulatory issues through presentations, dissemination of literature, and verbal or written correspondence. Performs other duties as assigned.Supervisory/Management Responsibilities This is a non-management job that will report to a supervisor, manager, director or executive.Minimum RequirementsEducation - Bachelor's degree in Biology, Nursing, Business, or Social Sciences related field of study.Experience - Five (5) years of research, Clinical Research, Regulatory-clinical or industry experience.In Lieu Of In lieu of experience listed above, three (3) years of related experience may be accepted if certified with either Certified Clinical Research Associate (CCRA) or Certified Clinical Research Professional (CCRP) or Master's degree in related field of study.Required Certifications, Registrations, LicensesClinical Research Certification preferred Knowledge, Skills and AbilitiesRegulatory interpretation and problem‑solving skills Organizational and project‑management skills Ability to lead without formal authority High attention to detail and documentation accuracy Collaborative, service‑oriented approach with clinical and administrative teams Work ShiftVariable (United States of America)LocationGreenville Memorial HospitalFacilityUpstate Administrative Research StaffDepartmentUpstate Administrative Research Staff-Practice OperationsShare your talent with us! Our vision is simple: to transform healthcare for the benefits of the communities we serve. The transformation of healthcare requires talented individuals in every role here at Prisma Health.Job SummaryJob number: R1143875Profession: Corporate