Clinical Research Regulatory Specialist A (Department of Otorhinolaryngology)

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Posted Job Title

Clinical Research Regulatory Specialist A (Department of Otorhinolaryngology)

Job Profile Title

Clinical Research Regulatory Specialist A

Job Description Summary

The Clinical Research Regulatory Specialist position will assist in maintaining regulatory compliance for the Department of Otorhinolaryngology. The RAS will provide regulatory support and expertise associated with clinical trials. The person will support a diverse group of investigators and coordinators involved in a broad spectrum of clinical trials. Involvement will range from consulting to serving as the primary regulatory contact for a study, handling all regulatory submissions, regulatory binders, monitor visits, and compliance checks.

With minimal supervision, the Clinical Research Regulatory Specialist will prepare and process all regulatory documentation through the IRB, CTSRMC, etc., and all applicable regulatory review committees- including new submissions, continuing reviews, amendments, adverse events, and reportable events. With minimal supervision, they will prepare and process all required regulatory documentation for pharmaceutical companies, contract research organizations (CROs), etc., and organize and maintain all regulatory affairs documentation/files as needed. The Clinical Research Regulatory Specialist is expected to resolve regulatory and data queries as required and participate in initiation, monitoring, audit, and close-out visits. They will participate in study team meetings, research team meetings, and ongoing protocol training/compliance meetings. The Clinical Research Regulatory Specialist is expected to facilitate the development of grant and clinical trial submission of applications and annual reports, development/maintenance of study-specific case report forms and source document tools, provide direct regulatory/compliance guidance, and facilitate investigator-initiated multi-site trials—additional duties relevant to regulatory affairs as assigned.

Job Description