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If you have experience with regulatory affairs and institutional review boards (IRBs) and have excellent customer service skills, you may be the right match for this IRB Manager position. Stanford University's IRB is charged with ensuring that all aspects of STANFORD’S Human Research Protection Program comply with all applicable laws, regulations, and policies, including standards of excellence necessary for maintaining accreditation status. This position, which is core to Stanford’s research compliance activities, focuses primarily on medical Research.
Under the direction of the Sr. HRPP Manager and the IRB Chair, the IRB Manager conducts in-depth protocol review using advanced regulatory knowledge and experience. S/he has primary responsibility to manage the protocol review process and identify issues, and to independently determine whether the components of the proposed research are in compliance with federal, state and local regulations, Stanford University policies, and accreditation standards. Other duties include serving as an expert liaison between the research investigator and the reviewer; educating parties on relevant and emerging regulations, and identifying related risk management issues
Develop, implement, and manage efficient procedures to facilitate the processing of human research protocols in accordance with Stanford, federal, accreditation, and state policies and procedures.
Perform review of complex research protocols, including identifying problems and issues in the submission application and contacting the investigator orally or in writing to request additional materials.
Plan and coordinate monthly IRB review and follow-up activities.
Serve as an expert liaison between the research investigator and the reviewer; educate parties on relevant and emerging regulations and related risk management issues.
Apply knowledge of federal, state, and local regulations, as well as university policies and practices, to ensure satisfactory compliance.
Provide assistance to management in preparation for accreditation and in various compliance and quality assurance activities.
Bachelor’s degree and three years of relevant experience, or combination of education and relevant experience.
Excellent customer service skills and ability to use tact and discretion.
Comprehensive knowledge of regulations and ethical principles regarding human subjects in research.
Demonstrated understanding of research procedures terminology, medical terminology, clinical trials, and research data management.
In-depth understanding of operational requirements pertaining to management and implementation of protocol process.
Strong knowledge of grants and contracts function.
Demonstrated strong verbal and written communication skills.
Institutional Review Board Professional Certification (CIP) desirable.
Stanford University, located between San Francisco and San Jose in the heart of California's Silicon Valley, is one of the world's leading teaching and research universities. Since its opening in 1891, Stanford has been dedicated to finding solutions to big challenges and to preparing students for leadership in a complex world.
Supporting that mission is a staff of more than 10,000, which is ro...oted in a culture of excellence and values innovation, collaboration, and life-long learning. To foster the talents and aspirations of our staff, Stanford offers career development programs, competitive pay that reflects market trends and benefits that increase financial stability and promote healthy, fulfilling lives. An award-winning employer, Stanford offers an exceptional setting for professionals looking to advance their careers.