Institutional Review & Regulatory Operations Specialist

The University of Maryland, Baltimore’s Research Compliance Departmentis recruiting for anInstitutional Review & Regulatory Operations Specialist. The selected candidate will apply entry level knowledge, concepts, principles, and skills regarding the protection of human subjects participating in research. The candidate will make decisions within defined parameters, with their supervisor providing guidance and support. The supervisor will define assignments, expectations, and deadlines and may review the work for quality. This support will give the Specialist the confidence to demonstrate initiative and discretion in resolving routine and non-routine matters. An institutional review board (IRB) is a committee that has been formally designated to approve, monitor, and review biomedical and behavioral research involving humans. It often conducts some form of risk-benefit analysis in an attempt to determine whether or not research should be done. The #1 priority of an IRB is to protect human subjects from physical or psychological harm. Benefits Information UMB offers acomprehensive benefits packagethat prioritizes wellness, work/life balance, and professional development, along withadditional exciting perksthat employees can take advantage of. This position participates in a retirement program that must be selected and is effective on your date of hire. Exempt regular staff receive a generous leave package that includes over 4 weeks of vacation accrued each year, paid holidays, unlimited accrual of sick time, and comprehensive health insurance; professional learning and development programs; tuition remission for employees and their dependents at any University System of Maryland school; and flexible work schedules and teleworking options (if applicable per job). UMB is a public university and constituent institution of the University System of Maryland. All employees are expected to work primarily physically within the State of Maryland. Primary Duties Support the administration of the UMB Institutional Review Board (IRB) activities. Provide administrative and logistical support to the IRB. Serve as liaison between the IRB/Human Research Protection Program (HRPP) and other departments or the community. Develop and schedule the IRB meeting activities in accordance with specifications and funding limitations; oversee daily operations and coordinates activities of the IRB; determine priorities. Confer with and advise staff, students and others to provide technical advice, problem solving assistance, answers to research compliance questions and HRPP goals and policy interpretation; refer to appropriate department person when able to respond. Coordinate activities of the IRB and the HRPP with interrelated activities of other programs, departments or staff to ensure optimum efficiency and compliance with appropriate policies, procedures and specifications. Review program documents independently and contact consultant and alternate members when required for scientific and ethical review. Develop, compile, and write communications and promotional literature for distribution such as IRB meeting materials, website content, etc. Performs other duties as assigned. Education:Bachelors degree in related field. Experience:Two (2) years of administrative/coordinator program experience. One (1) year experience with regulatory operations and administration governing use of human subjects preferred. Other:Familiarity with medical terminology preferred. Knowledge, Skills, and Abilities Knowledge of position requirements. Knowledge of all applicable requirements, regulations, and laws. Skill in effective use of applicable technology/systems. Ability to effectively communicate both verbal and written thoughts, ideas, and facts. Ability to work cooperatively with others and independently. Ability to demonstrate, understand, apply, and adhere to the UMB Core Values of Respect and Integrity, Well-being and Sustainability, Equity and Justice, and Innovation and Discovery. Hiring Range:$53,000 – $60,000, commensurate with education and experience. UMB is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law or policy. For assistance related to employment, please contact the Talent Recruitment department at HRJobs@umaryland.edu. If you anticipate needing a reasonable accommodation for a disability under the Americans with Disabilities Act (ADA), during any part of the employment process, please submit aUMB Job Applicant Accommodation Request. You may also contact HRDiversity@umaryland.edu. Please note that only inquiries concerning an ADA request for reasonable accommodation will be responded to from this email address. The University of Maryland, Baltimore prohibits sex discrimination in any education program or activity that it operates. Individuals may report concerns or questions to the Title IX Coordinator. Read theUMB Notice of Non-Discriminationfor more information. Job: Reg or CII Exempt Staff Organization: Research Compliance Title: Institutional Review & Regulatory Operations Specialist Location: null Requisition ID: 240001H6