Regulatory Affairs Coordinator

The University of Pittsburgh HIV/AIDS Clinical Research Site currently has more than 40 active clinical trials focused on HIV Treatment, HIV cure and HIV prevention research. This individual will provide regulatory support for these trials by preparing and submitting regulatory documents to internal and external agencies such as the University of Pittsburgh Institutional Review Board (IRB) and the Food and Drug Administration (FDA).

The Regulatory Affairs Coordinator must be able to interpret complex investigational drug studies, summarize the scientific content and draft consent forms and recruitment materials in lay language. The individual will also maintain all on site materials including regulatory binders, staff rosters, training records, and related documents. S/he will work collaboratively with the Research Manager, Research nurses, clinical staff and Data Manager to prepare site and study specific Standard Operating Procedures for all aspects of clinical trial implementation. Attention to detail, strong written and oral communication skills and ability to prioritize and manage deadlines are imperative for this position.

The individual must have at least two year prior experience working in a professional and/or administrative position required. Experience with OSIRIS is preferred. The individual must be familiar with medical terminology, organized, and detail oriented. Knowledge of Microsoft Office Suite is imperative

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PI96750408