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The Quality Assurance and Compliance Office within the Clinical Research Management Office (CRMO) of the University of Maryland, Baltimore School of Medicine, Marlene and Stewart Greenebaum Comprehensive Cancer Center (UMGCCC) is currently recruiting for a full-time Manager of Research Quality Improvement & Compliance. * Following an extensive training program, the Manager of Research QI and Compliance will lead a team of Quality Improvement and Compliance Analysts to monitor a portfolio of Cooperative Group (e.g., Big Ten, Hoosier) studies, as well as Investigator Initiated Trials currently being conducted at UMGCCC and at affiliate sites within the UMGCCC Network. The Manager of Research QI and Compliance will be responsible for the planning, conducting, and reporting of these monitoring activities to various study teams within the CRMO. The Manager of Research QI and Compliance will also be responsible for preparations for upcoming audits, as well as hold responsibility for the UMGCCC roster within the National Cancer Institute Clinical Trials Support Unit. The Manager of Research Quality and Compliance will interface directly with the Principal investigators on UMGCCC protocols as well as the research team within UMGCCC and sponsor representatives external to UMGCCC. UMB offers acomprehensive benefits packagethat 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). *Primary Duties * Manage the design, development, and execution of multiple research projects processes. Oversee research process 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. * Manage 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. Ensure content is current and accurately delivered on a regular basis. * Manage the quality improvement and compliance of routine and complex research regulatory and ethical requirements to researchers and research staff. Ensure monitoring reviews are conducted to facilitate education and training on a regular basis. * Advise researchers about routine and complex ethical standards, human subjects and animal protection issues; conducting education and training programs for researchers; and develop and implement communication strategy regarding relevant research compliance issues and external audit information. * Contributes to process improvement plans for quality assurance and compliance. * Facilitating Process Improvement initiatives using established practices, such as Six Sigma, operational issues identified by leadership spanning regulatory, clinical and administrative issues that occur during clinical trial execution. Present findings and recommendations from these projects to key stake holders for consideration. * Provide information 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. * Responsible for the internal reviews and implementation of recommendations from internal research review committees. * 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. * Represent department as an active member on the compliance committee to effectively evaluate deviation trends on protocols. * Enter protocol and subject deviations into the event reporting system, such as UMMC RL6. * 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. Ensure team is apprised and educated on the changes. * Manage databases ensuring accurate and comprehensive records of research activities are stored. Maintain attendance records and update/track education and training status in the program database for regulatory purposes. * Develop reports to comply with appropriate regulations. Provide routine and periodic reports on research activities to management and other audiences. * Manage the information delivery to internal campus and external stakeholders in connection with research compliance regulations, laws, guidelines, policies, and processes at UMB. * Performs other duties as assigned. Education:Bachelor’s degree in nursing, life or social sciences, law or ethics, or related field. Master’s degree preferred. Experience:Five (5) years of experience in clinical and/or laboratory research projects or related experience involving regulatory compliance issues including three (3) years must be direct experience in administration of IRB, clinical trials, or research administration. Supervisory Experience:Two (2) years in work coordination, training, and daily oversight of staff, students, or volunteers. Knowledge, Skills, and Abilities Thorough knowledge of position requirements. Thorough 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 support a mission and strategic vision. Instructional, training, and teambuilding skills to strengthen and cultivate relationships. Skill in consultation and change management. 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. /The Hiring Range for this position is in the mid $90,000s to low $110,000s, 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 aUMB 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. Job: Reg or CII Exempt Staff* *Organization: School of Medicine - Marlene and Stewart Greenebaum Comprehensive Cancer Center *Title: *Research Quality Improvement & Compliance Manager Location: null Requisition ID: 230001M8