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

Prisma Health; Greenville (SC); On-site; USD 60,000 - 85,000; Full time

Job summary

Prisma Health in Greenville Memorial Hospital is seeking a regulatory professional to prepare, submit, and oversee diverse regulatory documentation for research projects. You will coordinate requirements, support faculty and staff in collaborations, and act as a subject-matter expert during audits.

Requirements include a Bachelor’s degree in a related field and five years of research/regulatory experience, with Clinical Research Certification preferred.

Qualifications

• 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.
• Three (3) years of related experience may be accepted if certified with CCRA or CCRP or Master's degree in related field of study.
• Clinical Research Certification preferred

Responsibilities

• Prepares, submits, and assists with regulatory documentation for research.
• Participates in planning and project management of studies.
• Serves as a regulatory expert within the department.
• Oversees regulatory requirements for research; ensures timely submission to committees.
• Leads quality improvement initiatives related to regulatory compliance.
• Maintains training records for the research team.
• Educates the team on regulatory issues through presentations and literature.
• Performs other duties as assigned.

Skills

Regulatory interpretation

Organizational & project management

Lead without authority

Attention to detail

Collaboration & service orientation

Education

Bachelor's degree in Biology, Nursing, Business, or Social Sciences

Job description

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

• 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

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