Clinical Research Specialist

Clinical Research Specialist-(H)

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.

Benefits Information

UMB offers a 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, 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.

Primary Duties

• Performs as a single specialist in a clinical setting who is responsible for providing technical expertise to research programs and projects overseeing clinical research activities. The position develops, recommends, modifies, and implements policies and procedures for clinical research, as well as develop protocol manuals and data collection instruments. This position significantly contributes to the conduct of research.
• Coordinates the preparation of Institutional Review Board (IRB) and Health Insurance Portability and Accountability Act (HIPPA) protocol development and ensure compliance of research operations with protocols. Coordinates developing and recommending policies and procedures and / or design methods for clinical research activities.
• Manages interaction with subject participants including eligibility screening, recruitment, enrollment, ensuring informed consent is properly secured and documented, counseling, and obtaining patient medical history. May obtain tissue and blood samples as necessary and collects information through interviews, questionnaires, test results, and charts.
• Establishes and maintains database files and reports using computer applications such as Microsoft Excel / Access. Perform data checks, audits, and data cleaning. Check validity and accuracy of data ensuring compliance with quality control requirements and study relevance.
• Performs clinical research activities including advanced data analysis using statistical software such as SAS, SPSS, and R; data management (collection, entry, verification); data interpretation, and ensures compliance and clinical relevance of data. May develop data collection instruments such as survey questionnaires.
• Maintains communication with participants and colleagues regarding protocol specific information and research orders. Provides assessments and ensure protocol compliance while participants are in a study.
• Serves as liaison to other departments such as IRB or CCT, outside organizations, government agencies, and product representatives to promote effective and efficient operation and use of resources.
• Oversees and coordinates the day to day clinical research operations, study initiation, execution, and completion. Assist in the design and provide expert recommendation regarding research studies. Oversees interaction with subject participants including eligibility screening, recruitment, enrollment, ensuring informed consent is properly secured and documented, counseling, and obtaining patient medical history.
• May provide working coordination and feedback to others.
• Performs day-to-day operational duties such as : monitoring the budget; budget negotiation and review, ensuring quality control and safety compliance; serving as liaison with IRB, submitting invoicing, develops policies, procedures, and / or methods for laboratory experimentation; and ordering supplies.
• Searches relevant literature, develops conclusions on research findings, writes reports, prepare and deliver presentations of relevant findings and conclusions, and recommends appropriate actions. May conduct library research and contributes to the preparation and writing of research findings for publication of journal articles and grant proposals.
• Provides training to less experienced researchers; assisting in developing and submitting grants, papers, abstracts, manuscripts and presenting studies; developing protocol manuals and data collection instruments; participating in field visits, responding to requests and questions from individuals, institutions, government agencies, and funding agencies; and participating in the design of research studies.
• Performs other duties as assigned.

Qualifications

Education : Bachelor's degree in a scientific field of study or related to the research of the clinical setting.

Experience : Three years of clinical research experience including two years in the relevant research specialization. Prior experience with patients and patient interaction preferred.

Other : Some schedule flexibility may be required. Except for qualifications established by law, additional related experience and formal education in which one has gained the knowledge, skills, and abilities required for full performance of the work of the job class may be substituted for the education or experience requirement on a year-for-year basis with 30 undergraduate college credits being equivalent to one year of related experience. In instances where specific education and / or experience is required only directly related education and / or experience may be substituted.

Knowledge, Skills, and Abilities

Hiring Range : $63, - $75,, commensurate with education and experience.

The University of Maryland, Baltimore prohibits sex discrimination in any education program or activity that it operates. Individuals may report concerns or questions to the Title IX Coordinator. Read the

Reg or CII Exempt Staff-EEEmployee Class : Exempt RegularFull Time / Part Time : Full-Time

Shift

Day JobFinancial Disclosure : No

Organization

School of Medicine - Marlene and Stewart Greenebaum Comprehensive Cancer Center

Job Posting

Jan 22,

Unposting Date

Feb 21, , 11 : 59 : 00 PM

Salary : $63 - $75