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 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.
Develop and schedule the IRB meeting activities in accordance with specifications oversee daily operations of assigned caseload and coordinate activities for specific assigned IRB meetings; determine priorities.
Develop and conduct pre and post IRB meeting activities which includes IRB member notification and attendance confirmation, preparation of meeting agendas and other materials, execution of confidentiality agreements with members and guests, monitoring quorum during meetings, recording votes and determinations, and communicating 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 in accordance with federal regulatory requirements.
Interact and maintain liaison 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.
OR 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 to meet deadlines.
Ability to effectively communicate orally and in writing.
Hiring Range : 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.
Equal Opportunity/Affirmative Action Employer. Minorities, women, protected veterans, and individuals with disabilities are encouraged to apply.
The University of Maryland, Baltimore (UMB) is the State's public health, law and human services university devoted to excellence in professional and graduate education, research, patient care, and public service. As a diverse community of outstanding faculty, staff and students, and using state-of-the-art technological support, we educate leaders in health care delivery, biomedical science, globa...l health, social work and the law. We emphasize interdisciplinary education and research in an atmosphere that explicitly values civility, diversity, collaboration, teamwork and accountability. By conducting internationally recognized research to cure disease and to improve the health, social functioning and just treatment of the people we serve, we foster economic development in the City, State, and nation. We are committed to ensuring that the knowledge we generate provides maximum benefit to society and directly enhances our various communities.