Research Compliance Coordinator
Akron General Medical Center - Akron, OH

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Position Summary: Under the direct supervision of the Director, Research Administration and the Chairman of Medical Education/Research or designee, the Coordinator, Institutional Research and Compliance is responsible for the administrative and compliance activities of the IRRB and the coordination of all activities related to research compliance within Akron General Medical Center and the Health System. Works in collaboration with the IRRB Chairman, Research Administration and Corporate Compliance Officer in formulating and implementing a human subject protection program, meeting the requirements for Federal Wide Assurance, FDA and other federal, state, local and institutional regulations.Job Duties:
  • Reviews research protocols & amendments for completeness/compliance and assigns appropriate reviewers
  • Prepares agendas, meeting minutes, notification of approvals, and other correspondence
  • Acts as a resource for investigators, advises on deficiencies, notifies on actions & follow-up needed
  • Ensures all amendments, consent form revisions & adverse events are reviewed and approved
  • Maintains secure and adequate documentation for all IRRB activities
  • Conducts audits of research compliance issues in conjunction with Clinical Research Nurse
  • Coordinates peer review of investigator-initiated projects
  • Coordinates the program for investigator training and credentialing and training for IRRB members
  • Monitors human subjects' activities for compliance with applicable regulations & provides reports
  • Reviews, revises, formulates and disseminates policies, procedures and guidelines
  • Serves as voting member of the IRRB
  • Coordinates internal research seminars,symposiums and summer research fellowship program activities

association of Clinical Research Professionals - 13 months ago - save job - block
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