Research Quality Improvement %26 Compliance Analyst (full-time telework)
University of Maryland, Baltimore
Location: Baltimore, Maryland
Internal Number: 204128
Research Quality Improvement & Compliance Analyst (full-time telework)-(220000ZT)
The University of Maryland Marlene & Stewart Greenebaum Comprehensive Cancer Center (UMGCCC) is seeking aResearch QI & Compliance Analyst (Analyst, Research Quality Improvement & Compliance) to coordinate with regulatory and clinical coordinators. This position will also manage a caseload of clinical trials data for multiple oncology disease areas as it pertains to regulatory documentation, such as: collection and filing of medical licenses and CVs, signature collection, dissemination of updated documents, etc. This position serves in support of the regulatory team offering guidance to the UMGCCC Clinical Research Office staff in matters of human research protection laws, regulations, policies, procedures, and ethical standards.
The UMGCCC is a National Cancer Institute (NCI)-designated comprehensive cancer center which conducts innovative basic and clinical research that will impact the understanding and treatment of cancer around the world and seeks to provide state-of-the-art clinical care to cancer patients in Maryland and beyond. Private, foundation, and government sponsors provide funding to the Cancer Center to provide medical research treatment to cancer patients.
UMB offers a comprehensive benefits package that prioritizes wellness, work/life balance, and professional development. 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 and retirement options; 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 requires all faculty, staff, and students to be vaccinated against COVID-19. Exemptions for medical or religious reasons will be processed through Human Resources.
Responsible for collecting, tracking, and analyzing data pertaining to regulatory documentation.
Maintains up-to-date department information including faculty medical licenses, CVs, lab certifications, staff training certifications, etc. necessary to maintain compliance with study protocols. Coordinates and maintains data reports and database files on progress of research studies.
Receives, inventories, enters, and organizes collected data and regulatory documents.
Prepares and presents regulatory reports for presentation or submittal to sponsoring agent, Principal Investigators, and staff. Prepares and responds to audits conducted by study sponsors.
Assists in the preparation of initial and ongoing IRB submissions and proposals and maintains regulatory files for all research studies.
Determines reliability of data sources by evaluating information, determining errors, and notifying responsible parties.
Performs other duties as assigned.
Education: Bachelor's degree in Information Management, Biology, Health, or Social Sciences, Public Policy, Mathematics, Statistics, or another field of study related to the research.
Experience: One (1) year of experience in a clinical and/or laboratory research or related experience involving regulatory compliance issues.
Other: Related experience may be substituted for education.
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: $49,000 - $55,000, commensurate with related 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 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.
:Reg or CII Exempt Staff-E1454C
Employee Class :Exempt Regular
Full Time/Part Time:Full-Time
:School of Medicine - Marlene and Stewart Greenebaum Comprehensive Cancer Center
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.