University of Maryland, Baltimore
Cellular Therapies Research Specialist (Clinical Research Specialist)
University of Maryland, Baltimore, Seattle, Washington, us, 98127
University of Maryland, Baltimore - Cellular Therapies Research Specialist (Clinical Research Specialist)
The Bone Marrow Transplant and Cellular Therapy (BMT-CT) research team within the Clinical Research Management Office of the University of Maryland, Baltimore School of Medicine, Marlene and Stewart Greenebaum Comprehensive Cancer Center (UMGCCC) is currently recruiting for a full-time Bone Marrow Research Specialist (Clinical Research Specialist).Following an extensive training program, the Bone Marrow Research Specialist will be assigned a portfolio of cutting-edge Chimeric Antigen Receptor T-Cell Therapy (CAR-T) and other novel therapeutic trials and will be the primary interface, along with the faculty member, for cancer patients enrolled in the studies. The Bone Marrow Research Specialist will be responsible for screening, consenting, and enrolling patients as well as subsequently guiding them through procedures and visits required by the research protocol. The Bone Marrow Research Specialist is also responsible for data collection, resolving standard of care issues and direct research support. The Bone Marrow Research Specialist will interface directly with the Principal Investigators (PIs) on the protocols within their assigned portfolio as well as the medical care team, ancillary hospital staff, sponsor representatives, and data managers within UMGCCC.Primary DutiesPerforms as a single specialist in a clinical setting who is responsible for providing technical expertise to research programs and projects overseeing clinical research activities.Coordinates the preparation of Institutional Review Board (IRB) and Health Insurance Portability and Accountability Act (HIPAA) protocol development and ensure compliance of research operations with protocols.Manages and oversees interaction with subject participants including eligibility screening, recruitment, enrollment, ensuring informed consent is properly secured and documented.Establishes and maintains database files and reports using computer applications such as Microsoft Excel/Access.Performs clinical research activities including advanced data analysis using statistical software such as SAS, SPSS, and R.Maintains communication with participants and colleagues regarding protocol specific information and research orders.Serves as a liaison to other departments such as IRB or CCT, outside organizations, government agencies, and product representatives.Oversees and coordinates the day-to-day clinical research operations, study initiation, execution, and completion.Performs day-to-day operational duties such as monitoring the budget; ensuring quality control and safety compliance.Searches relevant literature, develops conclusions on research findings, writes reports, and prepares presentations of relevant findings.Provides training to less experienced researchers.Performs other duties as assigned.Education:
Bachelor's degree in a scientific field of study related to the research of the clinical setting.Experience:
Three (3) years of clinical research experience including two (2) years in the relevant research specialization.Knowledge, Skills, and AbilitiesAbility to understand and utilize scientific/medical terminology and research theory in both oral and written communications.Knowledge of human subjects research, the regulations and policies surrounding it.Ability to keep patient information confidential and possess knowledge of HIPAA regulations.The Hiring Range for this position is in the low $60,000s to low $70,000s, 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.
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The Bone Marrow Transplant and Cellular Therapy (BMT-CT) research team within the Clinical Research Management Office of the University of Maryland, Baltimore School of Medicine, Marlene and Stewart Greenebaum Comprehensive Cancer Center (UMGCCC) is currently recruiting for a full-time Bone Marrow Research Specialist (Clinical Research Specialist).Following an extensive training program, the Bone Marrow Research Specialist will be assigned a portfolio of cutting-edge Chimeric Antigen Receptor T-Cell Therapy (CAR-T) and other novel therapeutic trials and will be the primary interface, along with the faculty member, for cancer patients enrolled in the studies. The Bone Marrow Research Specialist will be responsible for screening, consenting, and enrolling patients as well as subsequently guiding them through procedures and visits required by the research protocol. The Bone Marrow Research Specialist is also responsible for data collection, resolving standard of care issues and direct research support. The Bone Marrow Research Specialist will interface directly with the Principal Investigators (PIs) on the protocols within their assigned portfolio as well as the medical care team, ancillary hospital staff, sponsor representatives, and data managers within UMGCCC.Primary DutiesPerforms as a single specialist in a clinical setting who is responsible for providing technical expertise to research programs and projects overseeing clinical research activities.Coordinates the preparation of Institutional Review Board (IRB) and Health Insurance Portability and Accountability Act (HIPAA) protocol development and ensure compliance of research operations with protocols.Manages and oversees interaction with subject participants including eligibility screening, recruitment, enrollment, ensuring informed consent is properly secured and documented.Establishes and maintains database files and reports using computer applications such as Microsoft Excel/Access.Performs clinical research activities including advanced data analysis using statistical software such as SAS, SPSS, and R.Maintains communication with participants and colleagues regarding protocol specific information and research orders.Serves as a liaison to other departments such as IRB or CCT, outside organizations, government agencies, and product representatives.Oversees and coordinates the day-to-day clinical research operations, study initiation, execution, and completion.Performs day-to-day operational duties such as monitoring the budget; ensuring quality control and safety compliance.Searches relevant literature, develops conclusions on research findings, writes reports, and prepares presentations of relevant findings.Provides training to less experienced researchers.Performs other duties as assigned.Education:
Bachelor's degree in a scientific field of study related to the research of the clinical setting.Experience:
Three (3) years of clinical research experience including two (2) years in the relevant research specialization.Knowledge, Skills, and AbilitiesAbility to understand and utilize scientific/medical terminology and research theory in both oral and written communications.Knowledge of human subjects research, the regulations and policies surrounding it.Ability to keep patient information confidential and possess knowledge of HIPAA regulations.The Hiring Range for this position is in the low $60,000s to low $70,000s, 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.
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