Description Job Summary: The Healthcare Research Regulatory Affairs Specialist serves as the central resource to investigators to assist with and provide regulatory guidance through experience and knowledge of related federal regulations (FDA). The Healthcare Research Regulatory Affairs Specialist closely partners with investigators and internal departments to deliver safe and effective research designs for clinical trials in line with institutional policies and procedures, and federal regulations. This may include study planning, start-up and implementation, Investigational New Drug (IND) applications, drug development and regulatory issues. Participates in training faculty and staff in the research community, as well as the developme
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