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Regulatory Affairs Assistant
Promotes and facilitates the regulatory compliance of the department by assisting the Regulatory Affairs Manager by independently completing a multitude of regulatory tasks; daily duties include submitting reports, amendments, and continuing reviews to the IRB, processing approved documents, creating essential study documents for regulatory files and outside sponsors, and creating and auditing all study regulatory documents; responsible for maintaining compliance by developing and exercising procedures to ensure timely document flow (paper and electronic) between the regulatory library, IRB, and outside sponsors; serves as short term back up in the event of the managers absence, including the preparation of IRB forms, sponsor and staff communications, and following established po


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