Director of Human Subject Compliance

University of Hawai’i Cancer Center, University of Hawai’i at Mānoa

The University of Hawaii Cancer Center (UHCC) is seeking a Director of Human Subject Compliance, who will be responsible for providing overall leadership, planning, & direction on all human subjectsí related federal & local regulations & grant/contract obligations including reporting requirements within the Center. This position oversees the UHCC Office of Compliance, is responsible to develop, implement, review, revise and provide oversight of the Standard Operating Procedures (SOPs), and conduct reviews and audits. The position assures compliance with the Centerís Data and Safety Monitoring Plan (DSMP), Clinical Trial Reporting Program (CTRP), privacy of protected health information and other National Cancer Institute (NCI) Cancer Center Support Grant (CCSG) human subjects research reporting requirements; conducts random internal audits of institutionally-generated clinical trials monitored by the Data and Safety Monitoring Committee (DSMC); liaises with local and federal regulatory agencies, the University of Hawaii (UH) Human Subjects Program, UH HIPAA Compliance Office, hospital Institutional Review Boards (IRBs), the Western Institutional Review Board, the National Cancer Institute (NCI) Central Institutional Review Board, and the federal Office for Human Research Protections (OHRP).

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