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The Clinical Research Management Office (CRMO) is a shared institutional resource of the Lombardi Comprehensive Cancer Center at Georgetown that provides administrative, nursing, and data management support for cancer treatment clinical trials conducted by Lombardi Investigators. The Clinical Research Manager oversees the implementation of clinical trials in the Lombardi Comprehensive Cancer Center ClRMO to ensure compliant management and support of clinical trials. S/he provides expert level knowledge in clinical trial practices and regulations. Working under the direct supervision of the CRMO Administrative Director and CRMO Medical Director as well as Principal Investigators to ensure safe implementation of oncology clinical trials, the Clinical Research Manager has duties that include but are not limited to:
Guides and directs a team of clinical research nurses and coordinators assigned to the various disease teams within the CRMO.
Provides support, direction and coaching to clinical research coordinators in the areas of hiring, training, disciplinary action, problem resolution, planning, and work assignment delegation.
Provides daily management/supervision to the clinical research coordinators to promote maximum enrollment, safe participation and exemplary conduct, and generation of accurate and complete data of the clinical research activities within the CRMO.
Oversees adherence to SOPs, Good Clinical Practice, and FDA regulations.
Ensures that accrual data and each subject data is entered into the study calendars in Clinical Trial Management System (CTMS) OnCore.
Assists CRMO leadership in developing strategic planning goals and initiatives for clinical research.
Liaises and works efficiently with other department at the University to ensure adequate financial accounting regarding clinical research projects, including budget development and reconciliation.
Interacts on a daily basis with the CRMO Regulatory Manager, CRMO Senior Data Managers and CRMO Lab and Imaging Technicians to ensure all protocol requirements are met.
Works with study sponsors, IRB, and other regulatory offices as needed.
Bachelor's degree, preferably in a scientific field
5 years of clinical research experience
Knowledge of clinical research, human subjects research ethics, and IRB procedures
Advanced knowledge of human subject's research ethics and clinical trial practices and policies to include ICH, GCP, FDA regulations, complex visit structures, budgets and contracts
Knowledge of medical terminology as well as the policies and regulations relevant to oncology clinical trials
Ability to build, lead, motivate, and assess a professional team
Excellent verbal and written communication skills in daily interactions with the ability to interpret and apply GUMC policies and federal, state, and local regulations
Strong organizational skills with the ability to manage large volumes of information
Experience in risk management regarding study subjects, federal and non-federal sponsors and regulating bodies
Knowledge of Microsoft Office (Word, Excel, PowerPoint and Outlook)
Master's degree in in scientific field with at least 3 years of supervisory experience
Nursing Degree and experience with management of oncology trials
Clinical Research Coordinator (CCRC) or Clinical Research Associate (CCRA) certification
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Internal Number: JR06225
About Georgetown University
Established in 1789, Georgetown is the nation's oldest Catholic and Jesuit University. Georgetown is one of the world's leading academic and research institutions, offering a unique educational experience that prepares the next generation of global citizens to lead and make a difference in the world.