The University of Kansas Office of Research is searching for an exceptional Human Research Protection Program (HRPP) Administrator to join our Research Integrity unit. The HRPP Administrator has primary responsibility for operations of the HRPP program on the KU-Lawrence campus. First review of applications begins March 25, 2019.
KU Lawrence HRPP provides oversight for human subjects research across the campus and serves all disciplines and research centers. The majority of research on the Lawrence campus is social-behavioral-education research (SBER), with some biomedical studies.
The HRPP Administrator reports to the director of Research Integrity in the Office of Research and works closely with Internal Review Board (IRB) members, the Institutional Official, investigators, compliance officers and research administrators to ensure University research involving human subjects is conducted ethically and in compliance with federal, state and local regulations and university policy and procedures. This is a core position in KU's research compliance activities.
50% Protocol Review:
Leads protocol review processes using regulatory knowledge and experience. Analyzes risk and determines appropriate review mechanism for protocols for research with human subjects.
Determines whether the components of the proposed research are in compliance with federal, state and local regulations and university policies.
Oversees designated review for protocols meeting expedited review criteria and provides documentation for full IRB.
25% HRPP Operations and Administrative Leadership:
Manages the day-to-day operations of the HRPP to ensure ethical and regulatory standards are met, provide assurance of regulatory compliance, and deliver excellent service to the research community. Oversees preparation for monthly IRB meetings. Maintains all required records.
Supervises professional and student staff. Trains staff to ensure quality, consistency and efficiency in all operations.
Works with Director of Research Integrity to ensure compliance policies, programs and procedures reflect changing regulations and emerging best practices. Implements initiatives (policy review, process improvement, program assessment, reporting metrics) for continuing improvement.
Addresses complex and/or sensitive issues in compliance, and drafts correspondence or executive summaries as needed to facilitate IRB or institutional responses.
Reviews reports of adverse events and/or noncompliance and in consultation with the IRB chair and director, works to resolve the issue as appropriate.
Prepares institutional reports on HRPP. Maintains federal-wide assurance. Represents HRPP on Conflict of Interest Committee and other relevant university compliance bodies. May represent Research Integrity in meetings when director is unavailable.
25% Education and Outreach:
Provides leadership to research community regarding HRPP awareness, policy, principles and resources.
Develops materials and makes resources such as web content, guidance documents, and training available.
Delivers training to various staff, IRB members, and researchers on ethical principles, federal regulations, policies and procedures and the use of HRPP compliance systems.
Master’s degree and 3 years of relevant experience or Bachelor’s degree and 6 years of relevant experience.
Comprehensive knowledge of regulations and ethical principles regarding human subjects research, including regulations and procedures for protecting sensitive information, as demonstrated by Current Certified IRB Professional (CIP) certification or eligibility to sit for CIP certification.
Excellent analytical abilities and strong written and verbal communication skills, as evidenced in work history, other relevant experience, application materials and possible interview.
Experience developing and delivering training and outreach programs and materials.
Work history that includes experience in a culturally diverse setting, working with all levels of personnel and requiring effective interpersonal communication and customer service skills.
Graduate degree. CIP Certification.
Experience with risk assessment and mitigation in SBER research. Knowledge of social-behavioral research methods. Experience conducting research involving human subjects.
Experience with program management and development that included projects in such areas as risk assessments, program reviews, business process analyses, development of training materials and methods, strategic communications, investigations, and internal and external reporting.
Knowledge of statistical methods and experience using reporting tools and developing meaningful metrics.
Experience using and training others to use an online documentation and workflow management system, such as Click.
Knowledge of and experience in a Research I university environment, including general knowledge of sponsored project administration.
Additional Candidate Instruction
A complete application consists of a cover letter, resume, and three professional references. Those offered an interview will be asked to submit samples of informational materials they have authored/created. Please use your cover letter to address how you meet the required and preferred qualifications. Incomplete applications will not be considered. An online University of Kansas application must be completed to be considered for this position.
Internal Number: 13696BR
About University of Kansas
The University of Kansas (KU) is a major public research and teaching institution of 28,401 students and 2,600 faculty. KU's diverse elements are united by its mission to educate leaders, build healthy communities, and make discoveries that change the world. A member of the prestigious Association of American Universities since 1909, KU consistently earns high rankings for its academic programs. Its faculty and students are supported and strengthened by endowment assets of more than $1.44 billion. KU is committed to expanding innovative research and commercialization programs. KU strives to recruit, develop, retain and reward a dynamic workforce that shares our mission and core strategic values in research, teaching and service.
KU's beautiful, historic main campus is located in Lawrence, Kansas.
The University of Kansas prohibits discrimination on the basis of race, color, ethnicity, religion, sex, national origin, age, ancestry, disability, status as a veteran, sexual orientation, marital status, parental status, gender identity, gender expression, genetic information and retaliation in the University's programs and activities.