Regulatory Coordinator, Research, Full Time, Days
2 weeks ago
Inspire health. Serve with compassion. Be the difference.
Job Summary
Prepares, submits, and assists with multiple levels of research documentation (i.e. IRB submissions, educational materials, reports, and study forms). Maintains regulatory documentation including consent forms, protocols, 1572s, CVs, licenses, Investigator Brochures, recruitment materials, safety reports, and submission forms. Drafts informed Consent Documents to meet Prisma Health standards. Participates in planning and project management of new and ongoing studies. May draft standard operating procedures related to position. Serves as a resource person or acts as a consultant within the area of clinical research regulatory expertise.Accountabilities
- Coordinates and oversees the regulatory requirements for Investigator Initiated Studies (resident and attending physician). Coordinates and oversees the regulatory requirements for sponsored or grant-funded studies. 20%
- Prepares, submits, and assists with multiple levels of research documentation (i.e. IRB submissions, educational materials, reports, and study forms). Maintains regulatory documentation including consent forms, protocols, 1572s, CVs, licenses, Investigator Brochures, recruitment materials, safety reports, and submission forms. Drafts informed Consent Documents to meet Prisma Health standards. Assures that IRB approvals do not inadvertently expire by submitting continuing review requests in a timely fashion.20%
- Coordinates, prepares, and submits protocol amendments, continuing review submissions, safety report submissions to the IRB. Responsible for informed consent document development, submissions of the document and modifications to the Informed Consent Document. Provides updates to study coordinators and manager of progress of all study submissions. Adheres to regulatory requirements set forth by the FDA, IRB or other regulatory agencies. 20%
- Tracks and monitoring all clinical research trials to assure that continuing renewals are submitted in a timely fashion and no lapse in approval occurs. 10%
- Provides support to physicians and staff with IRB submissions or issues. coordinates efforts with faculty and educational institutions involved in collaborative research with the Department of Surgery 10%
- Maintains regulatory documents for the Department of Surgery.5%
- Prepares regulatory documents for internal audits, sponsor audits or FDA audits. Acts as the departmental Clinical Research Regulatory expert during one of these audits. 5%
- Coordinates and maintains records for CITI training status for all faculty, house staff and research staff. 5%
- Educates the research staff, faculty and house staff on all regulatory issues through presentations, literature, and verbal or written correspondence. 5%
- 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 - Biology, Nursing, business, or social sciences
- Experience: 5 Years - Research/Clinical Research/Regulatory-clinical or industry
In lieu of
5 years of the experience listed above listed experience, 3 years will be accepted if certified with either Certified Clinical Research Associate (CCRA) or Certified Clinical Research Professional (CCRP) or Master's Degree in related field.
Required Certifications, Registrations, Licenses
CCRP or ACRP - Preferred
Knowledge, Skills and Abilities
- Extensive knowledge of regulatory compliance and documentation
Work Shift
Day (United States of America)Location
Cancer Centers - Faris RoadFacility
1008 Greenville Memorial HospitalDepartment
10617188 Peds Hem/Onc Office Services-PHOShare 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.
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