Job DescriptionThe University of Maryland, Baltimore Marlene & Stewart Greenebaum Comprehensive Cancer Center (UMGCCC) is seeking a full-time, exempt Lead Research Quality Improvement and Compliance Specialist.
The incumbent in this position coordinates and manages a caseload of clinical trials for multiple oncology disease areas as it pertains to regulatory transactions (i.e., 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 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.UMB offers a comprehensive and competitive benefits package to eligible employees. This position receives an annual leave package starting with 22 accrued vacation days, 14 floating and observed holidays, 15 sick days, and 3 personal days; comprehensive health insurance and retirement options; professional learning and development opportunities; flexible schedules and teleworking options; and tuition remission for employees and their dependents at any of the University System of Maryland schools.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.Primary Duties:
Lead the design, development, execution, and administration of research process. Oversee research processes by identification, and assessment of areas of research compliance risk and vulnerability; provide recommendations and ensure appropriate corrective actions are implemented; and the development of policy, Ensure adherence with all international, federal, state and local regulations, laws, policies and guidelines. Identify education and training needs and 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. Identifies needs for future training and develops training materials. Provide consultation and guidance on basic and complex research regulatory and ethical requirements to researchers and research staff. May lead mock monitoring reviews to facilitate education and training. Advise researchers about routine and complex ethical standards, human subjects and animal protection issues; develop and conduct education and training programs for researchers; and identify, develop, and implement a communication strategy regarding relevant research compliance issues and external audit information. Leads 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. Lead new protocols for FDA and IND submissions. Prepare the protocol and informed consent form for PI-initiated research studies and final PI approval. Provide subject matter expertise to researchers on basic and complex 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. Facilitate unit/school internal research review committees and leads the review process. Leads recommendations for process improvement to ensure implementation is completed. Develop, execute, and oversee an internal quality management program and the processes 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. Develop communication to apprise and educate on the changes. Conceptualize, develop, and maintain databases to store accurate and comprehensive records of research activities. Maintain attendance records and update/track IRB, FDA, and IND submissions in the program database for regulatory purposes. Serve as the Administrator for clinical trials. Report data of qualifying studies to federal agencies as assigned by PI. Facilitates the registry and reporting of qualifying clinical research studies and data to specified agencies. Develop reports to comply with appropriate regulations. Provide routine and periodic reports on research activities to management and other audiences. Develop and provide communication to internal campus and external stakeholders in connection with research compliance regulations, laws, guidelines, policies, and processes at UMB. Performs other duties as assigned.
Bachelor’s in nursing, life science, healthcare administration, public health, policy, law or related field of the research. Master’s preferred.Experience:
Four (4) years of experience in clinical and/or laboratory research projects or related experience involving regulatory compliance (1) years issues including three (3) years must be direct experience in administration of IRB, clinical trials, or research administrationSupervisory Experience:
One year of work coordination of staff. 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:
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 [email protected]
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 [email protected]
. Please note that only inquiries concerning an ADA request for reasonable accommodation will be responded to from this email address. Job:
Reg or CII Exempt StaffShift:
School of Medicine - Marlene and Stewart Greenebaum Comprehensive Cancer CenterJob Posting:
Jan 18, 2022Unposting Date: