Clinical Regulatory Liaison
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About The Position
iRhythm is currently seeking an experienced Clinical Regulatory Liaison who will support our Clinical Services Quality Assurance and process improvement. Duties include, but are not limited to, clinical complaint review, investigation reports, adverse event reporting, complaints log and trend maintenance. This role is a hybrid position and you will be required to work in an iRhythm office (Deerfield, IL Houston, TX two days/week). Specific functions will include, but not be limited to the following: Support Clinical Service Quality through maintaining and enforcing iRhythm's Clinical Quality Assurance System. Review and evaluate clinical complaints related to misclassified rhythm, missed arrhythmia notifications and skin irritations to assist with clinical complaint investigation. Assist with Clinical case review as part of the MDR process. Assist in maintaining Clinical compliance with regulatory requirements regarding misclassified rhythms, missed arrhythmia notifications. Assist with Regulatory remediation efforts, as needed. Perform and/or coordinate clinical complaint investigations and gathering of additional information including contacting accounts and/or patients. Perform frequent and timely review of MD Overread data and identify trends. Assist with reconciliation of registration discrepancies. Review and clinical investigation of tickets containing identified serious harm (hospitalization) or death. Work closely with Clinical Operations and Regulatory to complete investigation reports. Evaluate all information from a technical perspective to ensure appropriate analysis and investigation. Review daily processes to ensure issues are being addressed and escalated in a timely manner. Participate in process improvements. Assist in Joint Commission preparedness and continuous compliance, ISO and CMS audits. Perform other quality and regulatory-related duties as assigned. Provide feedback regarding any systems or concerns to the Clinical Quality Manager. Complete and pass all required training modules. Maintain compliance with job specific proficiency requirements, including CCT certification (RN or Paramedic may qualify). Adherence to HIPAA Guidelines and Good Clinical Practices. Other duties as assigned.
