Under the general supervision of Director of IRB, assists in research investigations in order to comply with federal, state and institutional policies/regulations regarding the conduct of biomedical research in health care institutions. Duties include but not limited to, the receipt, screening, data entry and tracking of all new and continuing applications; receipt and screening of Modifications and Serious Adverse Event Reports; to ensure conformance with applicable regulations, statutes, policies and procedures. Preparation of agendas and materials for committee meetings; prepare and issue IRB approval documents; Composes correspondence to researchers based on IRB decisions in compliance with 45 CFR 46 and 21 CFR 50 and 56; maintain records and filing systems; Process in-office expedited approvals, serious adverse events, non-compliance and protocol deviations; Maintain records and filing systems; and counsel investigators regarding application requirements.
Specifications: Associate’s Degree preferred with one to three years relatable experience, preferably in a medical setting, or equivalent combination of education and experience. Background in medical terminology helpful. Strong working knowledge of computer systems and applications required. Must have excellent interpersonal, communication, and organizational skills, and be fluent in the English language.