Regulatory Coordinator, Heart & Vascular Institute, Full Time, Variable
About The Position
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. 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. 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.
Requirements
- Bachelor's degree in Biology, Nursing, Business, or Social Sciences related field of study.
- Five (5) years of research, Clinical Research, Regulatory-clinical or industry experience.
- 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
Nice To Haves
- 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.
- Clinical Research Certification preferred
Responsibilities
- 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.
- Prepares, coordinates and oversees the regulatory requirements for research performed within the department.
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
