JOB SUMMARY Palo Alto University is seeking a knowledgeable, respected, goal-driven leader to join our team as the Administrator for its Human Research Protection Program (HRPP). The successful candidate will have experience in providing direction and administrative oversight to all core components of the institution's HRPP including IRB, Education and Training, and Quality Assurance and Improvement (QA/QI). The HRPP Administrator will oversee the facilitation and support of research reviewed by one Institutional Review Board (IRB) with a largely social behavioral portfolio, including the development and implementation of program goals and objectives. JOB DESCRIPTION • Process human subjects research protocols o Conducts pre-reviews of submissions (initial, continuing review requests, amendments, unanticipated problems, deviations, etc.) o Forwards submissions to the appropriate IRB member for review o Acts as liaison between the IRB and researchers, serving as a subject matter expert and primary point of contact o Coordinates IRB meetings o Creates IRB Meeting Agendas o Attends IRB meetings and drafts meeting minutes o Prepares correspondence to researchers in response to an IRB review o Makes exempt and/or not human subjects determinations • Conduct post-approval monitoring (for cause, and not-for-cause) of IRB approved activities. • Interpret current Federal, State, & University laws, regulations, policies and guidelines governing human subject research and apply them to Institutional policies and procedures as well as the electronic management system; and provide appropriate ongoing education and training. • Establish and implement goals and objectives for quality assessment and improvement (QA/QI) of the HRPP. Work closely with Institutional leadership, and ensure transparency with investigators, regarding these QA/QI efforts. • Serve as principal point of contact/liaison to both internal constituencies (e.g., investigators, legal counsel, business office, etc.) and external constituencies (e.g., study sponsors, federal and state oversight agencies) on professional and operational matters pertaining to the HRPP. • Develop & maintain positive relationships with collaborating organizations, ensure execution of appropriate reliance agreements. • Provide advice, guidance, and problem resolution to research investigators and support personnel in the application of relevant Federal, State, and University laws, regulations, and guidelines. • Assist with IRB-related non-compliance issues, as requested. ESSENTIAL QUALIFICATIONS • Bachelor’s degree • At least 5 years of experience directly related to the position • Strong written and verbal communication skills • Excellent attendance and punctuality, collegial and diplomatic behavior at work, and work performance to the satisfaction of management are essential functions of the position PREFERRED QUALIFICATIONS • Demonstrated work experience with increasing responsibility in a human subjects protection program. • Experience supervising or conducting human research. • Work experience in a University setting.
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