Research Regulatory Specialist, NHORA Research Operations, Days Part time 24hrs/wk 9a-430p at Norton Healthcare in Louisville, KY

Job description

Responsibilities Role is responsible for quality assurance, IRB submissions, and timeliness of reporting. This individual will oversee correspondence to the Norton-approved Institutional Review Boards, and ensure compliance with the internal Norton Healthcare Office of Research Administration (NHORA) requirements, Norton Healthcare policies, Good Clinical practice (GCP) for all phases of clinical trials, and local, state and federal regulations. This includes gathering all documentation for the submission of new protocols, amendments to protocols, and continuing annual review reports. Also, this position is responsible the maintenance of all federal and locally required regulatory documentation for every research study performed by a Norton Healthcare investigator. Candidate is responsible for representing NHORA to internal and external research professionals (e.g. Sponsors, Monitors, and Clinical Investigators) and regulators. Up to 10% local and national travel may be required. Qualifications Required: Three years research in a healthcare setting Bachelor Degree Desired: Master Degree Certified Clinical Research Associate OR Certified Clinical Research Coordinator OR Certified Clinical Research Professional