Clinical Research Regulatory & IRB Specialist

Norton Healthcare; Louisville (KY); Sur place; USD 65 000 - 90 000; Plein temps

Résumé du poste

Norton Healthcare is seeking an experienced professional to ensure quality assurance, manage IRB submissions, and oversee timely reporting for all studies conducted under NHORA. The role requires maintaining regulatory documentation and representing NHORA with sponsors, monitors, and investigators.

The candidate will coordinate protocol submissions, amendments, and annual reviews, and ensure compliance with GCP and applicable regulations. Travel up to 10% may be required.

Qualifications

• Three years of research in a healthcare setting (must-have).
• Bachelor Degree required. Master Degree preferred.

Responsabilités

• Quality assurance for clinical research programs and submissions.
• Oversee correspondence with Norton-approved Institutional Review Boards (NHORA) and ensure GCP compliance.
• Maintain regulatory documentation for every Norton Healthcare study and participate in sponsor/monitor/investigator communications.

Connaissances

Quality Assurance

GCP Knowledge

Regulatory Compliance

Formation

Bachelor Degree

Master Degree

Outils

Certified Clinical Research Associate

Certified Clinical Research Coordinator

Certified Clinical Research Professional

Description du poste

Norton Healthcare is seeking an experienced professional to ensure quality assurance, manage IRB submissions, and oversee timely reporting for all studies conducted under NHORA. The role requires maintaining regulatory documentation and representing NHORA with sponsors, monitors, and investigators.

The candidate will coordinate protocol submissions, amendments, and annual reviews, and ensure compliance with GCP and applicable regulations. Travel up to 10% may be required.