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The Human Research Protections Office (HRPO) has an opportunity for a Regulatory Operations Specialist. The HRPO is the coordinating office for the Human Research Protections Program, and provides support for the UMB Institutional Review Board (IRB) which conducts ethical review, compliance, and oversight activities for research conducted under the purview of the University of Maryland, Baltimore. The Regulatory Operations Specialist is responsible for supporting the administration of the UMB Institutional Review Board (IRB) for the Human Research Protections Program. Provides administrative and logistical support for all panels of the IRB and UMB’s Embryonic Stem Cell Research Oversight Committee (ESCRO). Serves as a liaison between the IRB/Human Research Protection Program and other departments or the community.
UMB offers a generous benefits package that includes 22 vacation days, 14 floating and holidays, 15 sick days; comprehensive health insurance and retirement options; and tuition remission for employees and their dependents at any of the University System of Maryland schools.
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In the Fall of 2021, UMB will require all faculty, staff, and students to be vaccinated against COVID-19. Exemptions for medical or religious reasons will be processed through Human Resources.
Develop and schedule the IRB meeting activities in accordance with specifications oversee daily operations of assigned caseload and coordinates activities for specific assigned IRB meetings; determine priorities.
Develop and conduct pre and post IRB meeting activities including IRB member notification and attendance confirmation, prepare meeting agendas and other materials, execute confidentiality agreements with members and guests, monitor quorum during meetings, record votes and determinations, and communicate review results.
Confer with and advise staff, students and others to provide technical advice, problem solving assistance, answers to research questions and Human Research Protection Program goals and policy interpretation; refer to appropriate department person when unable to respond.
Coordinate activities of the Institutional Review Board and Human Research Protections Program with interrelated activities of other programs, departments or staff to ensure optimum efficiency and compliance with appropriate policies, procedures and specifications.
Maintain databases used to collect and analyze research data, as well as to monitor and evaluate program operating policies and procedures.
Review program documents independently and contact consultant and alternate members when required for scientific and ethical review.
Develop, compile, and write IRB meeting minutes that meet federal regulatory requirements
Interact with students, faculty, staff and outside/community agencies in facilitating Human Research Protection Program objectives.
Perform other job-related duties as assigned.
Education: Bachelor’s degree in related field.
Experience: Two (2) years administrative/coordinator program experience. One year experience with regulatory operations and administration governing use of human subjects preferred.
Consideration may be given for a unique combination of education and experience.
Knowledge, Skills, and Abilities:
Ability to follow Human Research Protections Program Standard Operating Procedures.
Knowledge of federal and state regulations governing human subjects research.
Knowledge of organizational practices.
Skill in organizing work of self and others.
Ability to effectively communicate and meet deadlines.
The Hiring Range for this position is in the low to mid $50,000s, commensurate with education and experience.
If accommodations are needed for a disability, please contact Human Resource Services at 410-706-2606, Monday – Friday, 8:30am – 4:30pm EST. Maryland Relay can be accessed by dialing 711 (in-state) or 1-800-735-2258.
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 Staffing 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 a UMB 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.
UMB is Maryland's only public health, law, and human services university. Six professional schools and a Graduate School confer the majority of health care, human services, and law professional degrees in Maryland each year.
To improve the human condition and serve the public good of Maryland and society at-large through education, research, clinical care, and service.