Regulatory Coordinator, Heart & Vascular Institute, Full Time, Variable
Greenville, SC
Regulatory Coordinator, Heart & Vascular Institute, Full Time, Variable
Prepares and submits research regulatory documentation, supports audits, coordinates training records, and leads compliance improvement for clinical research. Variable shift; requires a bachelor's degree and 5 years of research/regulatory experience, or 3 years with CCRA/CCRP or a master's.
Inspire health. Serve with compassion. Be the difference.
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
Supervisory/Management Responsibilities
Minimum Requirements
In Lieu Of
Required Certifications, Registrations, Licenses
Knowledge, Skills and Abilities
Work Shift
Variable (United States of America)
Location
Greenville Memorial Hospital
Facility
Upstate Administrative Research Staff
Department
Upstate Administrative Research Staff-Practice Operations
Share 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 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.
- 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 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
- Clinical Research Certification preferred
Knowledge, Skills and Abilities
- 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
Upstate Administrative Research Staff
Department
Upstate Administrative Research Staff-Practice Operations
Share 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.