Lead Research Quality Improvement & Compliance Specialist

University of Maryland•Baltimore, MD

1d•$84,000 - $95,000•Hybrid

About The Position

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. This role accomplishes responsibilities by applying specialized and theoretical knowledge, principles, and concepts of a professional discipline normally acquired through advanced education or specialized training. The specialist resolves issues and significant matters on behalf of management by utilizing independent judgment, discretion, creativity, and analytical thinking. They contribute to the development and evaluation of goals and objectives, create solutions to ensure legal and policy compliance, and may supervise, mentor, or coordinate the work of others. The role may independently manage or administer programs, processes, projects, or resources, applying advanced, expert-level knowledge, concepts, principles, and skills with substantial latitude in decision making. The specialist sets goals and objectives to align with defined strategy, informs their supervisor of progress, and works on ambiguous matters generally without precedent or structure, independently developing standardization and protocol. They make departures from traditional approaches to develop novel solutions and influence strategy, program, policy development, and best practices, acting as an expert resource to others.

Requirements

Bachelors in nursing, life science, healthcare administration, public health, policy, law or related field of the research.
Four (4) years of experience in clinical and/or laboratory research projects or related experience involving regulatory compliance issues.
Three (3) years of direct experience in administration of IRB, clinical trials, or research administration.
One year of work coordination of staff.
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.

Nice To Haves

Master's preferred.
Minimum 2 years’ experience in a GLP laboratory supporting laboratory animal research.
Experience performing quality control (QC) review of study documentation and data, including raw data, study records, protocols, amendments, reports, and supporting documentation, and training others on QC procedures.
Experience using quality document management software.
Experience performing project management activities, including progress reporting, agenda/meeting minute preparation and coordination of study activities.

Responsibilities

Lead the design, development, execution, and administration of research processes.
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.
Identify needs for future training and develop 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.
Lead 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.
Communicate 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 lead the review process.
Lead 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 devise 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.
Facilitate 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.
Perform other duties as assigned.

Benefits

Retirement program (pension or optional retirement plan/ORP)
Generous PAID leave package
Over 4 weeks of vacation accrued each year
16 paid holidays
3 personal leave days
Unlimited accrual of sick time
Comprehensive health insurance
Professional learning and development programs
Tuition remission for employees and their dependents at any University System of Maryland school
Flexible work schedules
Teleworking options (if applicable per job)