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

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 Healths purpose: Inspire health. Serve with compassion. Be the difference.

• In accordancewithlocalfederaland study-specificrequirements preparescoordinatesand oversees the regulatory requirements forresearch performed within ofphases ofresearch regulatory documentation to local and external committees.

• Provides support to physicians and staffwhencoordinatingeffortsbetweenfaculty and educational institutions involved in collaborative research.

• Prepares regulatory documents for internal audits sponsormonitoring visits orauditsorFood and Drug (FDA)audits. Acts as thesubject matterexpert duringaudits.

• Leads Quality Improvement initiatives related to regulatory compliance.

• Coordinates andmaintainstrainingrecords.

• Educates the researchteamonregulatory issues through presentationsdissemination ofliterature 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 - Bachelors degree in Biology Nursing Business or Social Sciencesrelated 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 Masters degree in related field of study.

Required Certifications Registrations Licenses

• Clinical Research Certification preferred

Knowledge Skills and Abilities

• Regulatory interpretation and problemsolvingskills

• Organizational and projectmanagement skills

• Ability to lead without formal authority

• High attention to detail and documentation accuracy

• Collaborative serviceoriented 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.