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Research Regulatory Analyst

Women & Infants Providence, RI
  • Posted: over a month ago
  • Part-Time
  • Benefits: Vision, Medical, Life Insurance, Dental

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.

Women & Infants

A career in the health care field is rewarding and fulfilling. Care New England, one of the leading health care systems in southern New England is constantly looking to fill health care jobs located throughout Rhode Island and southeastern Massachusetts. Women & Infants Hospital of Rhode Island, a Care New England hospital, is one of the nation’s leading specialty hospitals for women and newborns. The major teaching affiliate of The Warren Alpert Medical School of Brown University for activities unique to women and newborns, Women & Infants is the 9th largest stand-alone obstetrical service in the country with approximately 8,500 deliveries per year. A Designated Baby-Friendly USA Hospital, U.S.News & World Report 2014-15 Best Children’s Hospital in Neonatology and a 2014 Leapfrog Top Hospital, in 2009, Women & Infants opened what was at the time the country’s largest, single-family room neonatal intensive care unit. WIH Accreditations & Awards

Address

101 Dudley Street, Providence RI 029015
Providence, RI
USA

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