The Human Research Protections Office (HRPO) has an opportunity for an Institutional Review Board (IRB) Analyst. 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 and scientific review, compliance, and oversight activities for research conducted under the purview of the University of Maryland, Baltimore. The IRB Analyst provides high level technical and administrative analysis in the review of human research requests, utilizing predetermined standards that do not require review by the IRB committee. The analyst determines if sufficient expertise is available to approve requests, and provides support and guidance to investigators from initial proposal review and submission through completion of the study.
Benefits Information 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.
Performs non-committee review of human research requests and utilize predetermined standards that do not require review by the IRB committee to determine and ensure request is compliant with all applicable laws and regulations.
Initiates assessment of human subject research proposals, ensuring compliance with Office, University, and FDA policies.
Determines IRB requirements of approval are met and issue approval documentation or other appropriate documentation.
Writes clear and detailed correspondence to investigators.
Maintains clear and accurate IRB files both electronic and hard copies.
Ensures ethical issues are addressed.
Provides support and guidance to investigators from initial proposal review and submission through completion of the study. Serve as liaison between IRB and investigators.
Performs other duties as assigned.
Education: Bachelors in related field
Experience: Four (4) years experience working in research administration, including use of human subjects
Knowledge, Skills, and Abilities
Knowledge of federal and state regulations governing human subjects research.
Ability to work independently and as a member of a team.
Skill in exercising initiative, discretion and tact, resourcefulness, and sound judgment with an ability to solve problems and make decisions.
Skill in writing detailed, clear, precise, and grammatically correct technical letters, memos and reports.
Skill in relevant PC applications.
Skill in communicating efficiently and effectively both orally and in writing with a variety of people internal and external to the organization.
Hiring Range: Commensurate with education and experience The target range for this position is low to mid $60's
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.
Job: Reg or CII Exempt Staff - E1457F
Employee Class : Exempt Regular
Full Time/Part Time: Full-Time
Shift: Day Job
Organization: Research Compliance
Job Posting: May 11, 2018
Unposting Date: Ongoing
Internal Number: 90801
About University of Maryland, Baltimore
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, global 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.