Research Quality Improvement & Compliance Specialist (remote – region restricted)

The University of Maryland, Baltimore Marlene & Stewart Greenebaum Comprehensive Cancer Center (UMGCCC) is seeking 2 full-time, exempt Research Quality Improvement and Compliance Specialists. The specialist coordinates and manages a caseload of clinical trials for multiple oncology disease areas as it pertains to regulatory transactions (e.g., IRB submissions). The incumbent in this position provides guidance to the UMGCCC Clinical Research Office staff in matters of human research protection laws, regulations, policies, procedures, and ethical standards.

Fully remote work schedule starting in January 2022 with on campus meetings as needed but not to exceed once per quarter. The Cancer Center will provide equipment necessary to perform the job, such as computers, printers, cables, and/or other software as needed pursuant to the UMB Policy on Telework. This is a full-time exempt position that will work Monday through Friday. Some schedule flexibility may be required.

Employees of UMB must be residents of Maryland, the District of Columbia, or one of the states that are contiguous to Maryland: Delaware, Pennsylvania, Virginia, and West Virginia.
 
UMB offers a comprehensive benefits package that prioritizes wellness, work/life balance, and professional development. This position participates in a retirement program that must be selected and is effective on your date of hire. 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; 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 employees are strongly encouraged to follow all CDC recommendations related to COVID-19 vaccinations and booster doses. Employees whose job duties require them to work in clinical settings or at clinical or field sites continue to be subject to the vaccine requirements of those sites. For additional information on protocols and exemptions, please visit the COVID-19 website.

ESSENTIAL FUNCTIONS:

• Design, develop, execute, and administer research implementation processes which include the identification and assessment of areas of research compliance risk and vulnerability; and implementation of recommendations to ensure appropriate corrective actions; and implementation of policy, Ensure adherence with all international, federal, state and local regulations, laws, policies and guidelines.
• Consult and guide researchers and research staff on current research regulatory and ethical requirements. May conduct training and mock reviews to facilitate education and training. Advise researchers about ethical standards, human subjects and animal protection issues; develop and conduct education and training programs for researchers; and identify, develop, and implement communication strategies regarding relevant research compliance issues and external audit information.
• Facilitate new research studies, to include the informed consent, for Departmental and Institutional Review Board (IRB) review in the IRB’s electronic system.
• Process continuing reviews and amendments for IRB approved studies before submission deadlines. Communicates with the Institutional Review Board (IRB) to resolve administrative modifications and address queries.
• Facilitate and complete new protocols for FDA and IND submissions. May assist principal investigators in preparing the protocol and informed consent form for PI-initiated research studies.
• Provide advance knowledge-based information to researchers in basic and complex protocol development, study conduct, clarification and documentation of study procedures, maintenance of study records, IRB submissions and modifications, conflict of interest, data security, and reporting requirements.
• Facilitate unit/school internal research review committees.
• Develop, execute, and oversee an internal quality management processes to ensure 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. Provide information and recommendations to researchers of changes.
• Devise strategies to successfully implement required updates.
• Develop and maintain databases to store accurate and comprehensive records of research activities. Maintain attendance records and update/track IRB and FDA submissions in the program database for regulatory purposes.
• Develop and prepare reports to comply with appropriate regulations on research activities to management and other audiences.
• Provide information to internal campus and external stakeholders in connection with research compliance regulations, laws, guidelines, policies, and processes at UMB.
• Perform other duties as assigned.

Education: Bachelor’s degree in nursing, life science, healthcare administration, public health, policy, law or related field of the 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 administration.

Certfication/Licensure: SOCRA certification preferred.
 
Other: Related experience may be substituted for education.
 
KNOWLEDGE, SKILLS, AND ABILITIES

• Ability to understand and utilize scientific/medical terminology and research theory in both oral and written communications.
• Ability to perform independent projects.
• Ability to network with and provide information to key groups and individuals, and work as part of a team.
• Knowledge of human subjects research including the regulations and policies surrounding it.
• Prior experience with patients and patient interaction.
• Ability to represent the Cancer Center and its faculty in a professional manner.
• Ability to keep patient information confidential, knowledge of HIPPA regulations.

Hiring Range: $72,000-78,000; Commensurate with 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.