Clinical Research Regulatory Coordinator-CEDAS

UNC-Chapel HillChapel Hill, NC
Onsite

About The Position

This position will serve as a Clinical Research Regulatory Coordinator within the Center for Gastrointestinal Biology and Disease. The Clinical Research Participant Regulatory Coordinator is responsible for research regulatory management for a variety of complex clinical research protocols, including leading efforts in creating, gathering, editing, compiling, and reporting regulatory information. The Clinical Research Regulatory Coordinator will analyze and reconcile information from various sources to complete various regulatory based tasks, such as Institutional Review Board submissions and applications management, creation and maintenance of regulatory files, and quality assurance activities.

Requirements

  • Clinical research regulatory management experience
  • Experience with Institutional Review Board submissions and applications
  • Experience in creating and maintaining regulatory files
  • Quality assurance experience

Responsibilities

  • Research regulatory management for a variety of complex clinical research protocols
  • Leading efforts in creating, gathering, editing, compiling, and reporting regulatory information
  • Analyzing and reconciling information from various sources to complete various regulatory based tasks
  • Institutional Review Board submissions and applications management
  • Creation and maintenance of regulatory files
  • Quality assurance activities
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