Research Quality Improvement & Compliance Specialist
- Employer
- University of Maryland Baltimore
- Location
- Baltimore, MD
View more
- Administrative Jobs
- Academic Affairs, Research Staff & Technicians, Institutional & Business Affairs, Assessment, Accreditation & Compliance
- Employment Type
- Full Time
- Institution Type
- Four-Year Institution
Job Details
University of Maryland, Baltimore (UMB) is currently seeking a Research Quality Improvement & Compliance Specialist to join the Department of Vascular Surgery team of nationally recognized specialists. UMB was ranked one of America's Best Large Employers by Forbes Magazine (Feb 2021). BENEFITS:This EXEMPT position 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. 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. PRIMARY DUTIES:• Design, develop, execute, and oversee research implementation processes which include the development of policy, identification, and assessment of areas of research compliance risk and vulnerability, and provision and implementation of recommendations to ensure appropriate corrective actions. Ensure adherence with all international, federal, state, and local regulations, laws, policies, and guidelines. • Manage, initiate, standardize, develop, and deliver education and training to researchers and research staff on the application and implementation of federal, state, and international regulations, laws, guidelines, University policies and practices, ethical standards, responsible conduct of research and good clinical research practices for human subjects and animals. • Provide consultation and guidance on regulatory and ethical requirements in research to researchers and research staff. Conduct mock monitoring reviews to facilitate education and training. Advise researchers about ethical standards, human subjects and animal protection issues; conducting education and training programs for researchers; and developing and implementing a communication strategy regarding relevant research compliance issues and external audit information. • Provide subject matter expertise to researchers in protocol development, study conduct, regulatory binder preparation, clarification and documentation of study procedures, maintenance of study records, IRB submissions and modifications, conflict of interest, data security, and reporting requirements. • Serve as a reviewer and facilitator for the unit/school internal research review committees. • Develop, execute and oversee an internal quality management program to facilitate compliance with research requirements, identify areas of risk, and implement corrective action plans. Facilitate resolution of regulatory issues as needed. • Research and remain abreast of federal, state, and local laws as well as University policy to identify changes regarding statutes and rulings that might affect research projects and compliance. Notify researchers of changes and devises strategies to successfully implement required updates. • Conceptualize, develop, and maintain databases to store accurate and comprehensive records of research activities. Maintain attendance records and update/track education and training status in the program database for regulatory purposes. • Develop reports to comply with appropriate regulations. Provide routine and periodic reports on research activities to management and other audiences. • Provide direction and information to internal campus and external stakeholders in connection with research compliance regulations, laws, guidelines, policies, and processes at UMB. • Performs other duties as assigned.
Qualifications
Education: Bachelors in nursing, life science, healthcare administration, public health, policy, law, or related field of research. Master’s preferred.Experience: Three (3) years of experience in clinical and/or laboratory research projects or related experience involving regulatory compliance issues including two (2) years must be direct experience in administration of IRB, clinical trials, or research administrationOther: Related experience may be substituted for education. KNOWLEDGE, SKILLS AND ABILITIES:
- Accomplishes responsibilities by applying specialized and theoretical knowledge, principles, and concepts of a professional discipline normally acquired through advanced education or specialized training. Resolves issues and significant matters on behalf of management by utilizing independent judgment, discretion, creativity, and analytical thinking. Contributes to development and evaluation of goals and objectives. Creates solutions to ensure legal and policy compliance. May supervise, mentor, or coordinate work of others (positions that supervise are responsible for service delivery, quality assurance, and employee performance). May independently manage or administer programs, processes, projects, or resources. Applies intermediate level knowledge, concepts, principles, and skills. Decision making occurs within general guidelines and requires significant interpretation. Supervisor defines work guided by goals and objectives. Supervisor assists with unusual situations. Solutions require considerable analysis and evaluation of various alternatives. Independently anticipates needs and requirements to resolve non-routine matters.
Job: Reg or CII Exempt Staff
Shift: Day Job
Organization: School of Medicine - Surgery
Job Posting: Jul 16, 2021
Unposting Date: Jul 23, 2021, 10:59:00 PM
Organization
Welcome to the Baltimore campus of the University of Maryland, founded in 1807 along a ridge in what was then called Baltimore Town. Today, this 61-acre research and technology complex encompasses 65 buildings in West Baltimore near the Inner Harbor. 
The University is Maryland's only public academic health, human services, and law center. Seven professional and graduate schools train the majority of the state's physicians, nurses, dentists, lawyers, social workers, and pharmacists.
Under the leadership of President Jay A. Perman, MD, the University is a leading partner in the redevelopment of the west side of Baltimore. The University of Maryland BioPark, which opened in October 2005, promotes collaborative research opportunities and bioscience innovation.
Sponsored research totaled $567.1 million in Fiscal Year 2010. With 6,349 students and 6,717 faculty members and staff, the University is an economic engine that returns more than $15 in economic activity for every $1 of state general funds appropriation. The University community gives more than 2 million hours a year in service to the public.
Mission
The University of Maryland, Baltimore (UMB) is the State¹s 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.
Campus Data
Go to the Office of Institutional Research and Accountability for complete campus facts.
Equal Opportunity
The University of Maryland is an Equal Opportunity/Affirmative Action employer and educational institution and does not discriminate on the basis of race, color, religion, age, ancestry, national origin, gender, sexual orientation, physical or mental disability, marital status or veteran's status to recruit, hire, compensate, train and promote employees and applicants for employment in all job levels with regard to their qualifications and without consideration to the aforementioned categories. Exceptions to this policy will be made only as allowed by law for example, due to bona fide occupational qualifications or lack of reasonable accommodations for disabilities.
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