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

Job Summary

Prepares, 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 Functions

• All 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.
  • Led Quality Improvement initiatives related to regulatory compliance.
  • Cohorts and maintains training records.
  • Edits 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 Requirements

• Education - 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, Licenses

Regulatory 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 Shift

Variable (United States of America)

Location

Greenville Memorial Hospital Facility

Facility

Upstate Administrative Research Staff

Department

Upstate Administrative Research Staff-Practice Operations