Lead Research Quality Improvement & Compliance Specialist

The University of Maryland, Baltimore (UMB) is currently seeking a Lead Research Quality Improvement & Compliance Specialist to join their team in the School of Medicine - Department of Radiation Oncology.

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 advanced, expert level knowledge, concepts, principles, and skills. Substantial latitude in decision making. Sets goals and objectives to align with defined strategy. Informs supervisor of progress. Works on ambiguous matters generally without precedent or structure and independently develops standardization and protocol. Makes departures from traditional approaches to develop novel solutions.

Influences strategy, program, policy development, and best practices. Acts as expert resource to others.

UMB offers a comprehensive benefits package that prioritizes wellness, work/life balance, and professional development, along with additional exciting perks that employees can take advantage of. This position participates in a retirement program (pension or optional retirement plan/ORP) that must be selected and is effective on your date of hire. Exempt regular staff receive a generous PAID leave package that includes over 4 weeks of vacation accrued each year, 16 paid holidays, 3 personal leave days, 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 is a public university and constituent institution of the University System of Maryland. All employees are expected to work primarily physically within the State of Maryland.

• 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…