Classification Title: Manager/Administrator Position Number: 01203822 Hours Per Week: 40 Department: Office of Compliance Campus Location: Kansas City Metro
Position Summary: The University of Kansas Medical Center (KUMC) seeks an experienced IRB professional to serve as Senior Manager for IRB Reliance for the Human Research Protection Program (HRPP). KUMC is one of 26 U.S. universities that have a National Cancer Institute-designated cancer center, a National Institute on Aging-designated Alzheimer's disease center and a National Institutes of Health Clinical and Translational Science Award. Accredited since 2007, the HRPP participates in SMART IRB, CTSA's Trial Innovation Network, NIH StrokeNet and PCORnet Greater Plains Collaborative as well as multiple other single IRB arrangements.
The Senior Manager for Reliance is responsible for the oversight, administration, implementation, and management of policies and procedures for KUMC research that is conducted under single IRB review. This includes KUMC serving as the Reviewing IRB as well as relying on external IRBs. This position manages the reliance relationships with academic institutions, research consortia and commercial IRBs. The Senior Manager analyzes federal regulations, state laws, institutional policies and best practices to recommend enhancements to the IRB reliance program. The position interfaces with university legal counsel to consult about new reliance arrangements and compliance issues related to IRB reliance. The position provides priority setting and work flow analysis to ensure efficient and effective reviews. The position supervises one or more staff members dedicated to IRB reliance. This position involves occasional travel to professional events.
Required Qualifications: • Bachelor’s degree in a healthcare discipline, business, public administration or a related field • At least 3 years progressively responsible experience in an IRB office resulting in extensive knowledge of federal regulations related to human subjects research • Prior experience in the area of IRB reliance • Strong analytical and problem-solving skills as well as proven skills in organizational leadership and team-building • Demonstrated ability to exercise independent judgment and work successfully in a highly regulated environment • Highly effective written, oral communication skills, interpersonal skills and sound judgment necessary to work collaboratively with faculty investigators, study teams, senior leadership, university legal counsel, IRB colleagues and federal regulators. • High degree of skill and aptitude for working in an electronic environment. • Applicants must submit a cover letter addressing exactly how experience and qualifications meet the requirements of this job
Preferred Qualifications: • Master’s degree or juris doctorate • Designation as a Certified IRB Professional (CIP) • Prior leadership in an IRB reliance program
Environment: Office Physical Requirements: Light
Probation Status: Subject to the regulations of the State of Kansas, the Board of Regents and the University of Kansas Medical Center, I understand and agree that I may be subject to a probation period and during the probation period I serve at the pleasure of the Executive Vice Chancellor of KUMC and my employment may be ended at any time during that period.
Apply knowledge of federal, state, and local regulations and institutional policies governing human subject research including, HHS regulations, and FDA regulations for the use of investigational drugs, biologics and devices, to IRB reliance determinations.
Evaluate requests for the KUMCIRB to serve as the Reviewing IRB based upon federal regulations, institutional policy and accreditation standards; provide budget estimates for single IRB services.
When KUMC is the Reviewing IRB, provide leadership to the initial IRB review process and evaluation of study team readiness; supply training and consultation to the lead study team as needed. After initial IRB approval, oversee the process to onboard relying sites.
Identify state laws and other local context considerations at relying sites that trigger non-routine compliance requirements, and additional compliance risk, for KUMC. Ensure supplemental training and monitoring for the KUMC study team or for relying site personnel.
Implement and oversee the fee structure for serving as the Reviewing IRB.
Direct the communications with relying institutions to collaboratively investigate reports of unanticipated problems or protocol non-compliance.
Approve reliance requests for reviews by non-KUMC IRBs. Manage institutional boilerplates for commercial and federally-funded IRBs.
Actively monitor changes in federal regulations and establish collegial relationships with counterparts at other institutions to implement best practices related to IRB reliance.
Evaluate and improve the educational resources and tools for the research community related to IRB reliance.
Recommend new procedures and business processes to benefit the efficiency and effectiveness of the KUMCIRB reliance program. Set priorities and implement plans to improve IRB reliance metrics.
Other related duties to support the Human Research Protection Program
Applications must be submitted directly through the KU Medical Center website to be considered for this position. Any applications submitted via email or this website will NOT be reviewed or considered.
About KU Medical Center: The University of Kansas Medical Center’s mission is to educate exceptional health care professionals through a full range of undergraduate, graduate, professional, postdoctoral and continuing education programs in the schools of Medicine, Nursing and Health Professions. KU Medical Center also advances the health sciences through world-class research programs; provides compassionate and state-of-the-art patient care in an academic medical center environment; and works with communities in every Kansas county to improve the health of Kansans. Learn more at www.kumc.edu.
Benefits: KU Medical Center proudly offers a competitive and comprehensive benefits package through the state of Kansas, with flexible options designed to meet the diverse needs of our faculty and staff. To learn more about our options for medical, vision, dental and other insurances, as well as our generous time off policies and retirement options, please visit http://www.kumc.edu/human-resources/benefitsrewards.html.
KU Medical Center is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disability status, or genetic information.
The University of Kansas Medical Center’s mission is to educate exceptional health care professionals through a full range of undergraduate, graduate, professional, postdoctoral and continuing education programs in the schools of Medicine, Nursing and Health Professions. KU Medical Center also advances the health sciences through world-class research programs; provides compassionate and state-of-the-art patient care in an academic medical center environment; and works with communities in every Kansas county to improve the health of Kansans. Learn more at www.kumc.edu.
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