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Director of Regulatory AffairsDenver Research Facility - Denver, CODEPARTMENT: Academic AffairsREPORTS TO: EVP of Academic AffairsPURPOSE:To manage the budgetary, organizational and regulatory processes for reviewing and approving human subject clinical trials and animal research conducted at the institution.ESSENTIAL RESPONSIBILITIES:1. Demonstrates advanced knowledge of Food and Drug Administration (FDA), Office of Human Research Protections (OHRP) and National Institutes of Health (NIH) regulations and requirements related to human subject clinical research; demonstrates ability to interpret and apply complicated federal regulations and internal policies to research protocols. Works with Research Administration to develop methods to ensure compliance with human subject NIH requirements.2. Demonstrates knowledge of Office of Laboratory Animal Welfare (OLAW),...originally from HH - More Tools...
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