Clinical Research Specialist

Job Description

The University of Maryland, Baltimore (UMB) Marlene & Stewart Greenebaum Comprehensive Cancer Center (UMGCCC) has an exciting opportunity for a full-time Clinical Research Specialist for the Solid Tumor research program. Following an extensive training program, the Clinical Research Specialist will be assigned a portfolio of cutting-edge novel therapeutic trials and will be the primary interface, along with the faculty member, for cancer patients enrolled in the studies. The Clinical 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 Research Specialist is also responsible for data collection, resolving standard of care issues and direct research support. The Clinical Research Specialist will interface directly with the Principal investigators on the protocols within their assigned portfolio as well as the medical care team, ancillary hospital staff, Sponsor representatives, and data managers within UMGCCC.

This full-time position works Monday through Friday and work scheduling flexibility that includes working outside of normal working hours is highly preferred.

Essential Functions

• 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 (3) years of clinical research including two (2) years in the relevant research specialization. Prior experience with patients and patient interaction preferred.
Other: 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.

Some schedule flexibility is highly preferred.

Knowledge, Skills, and Abilities

• Ability to understand and utilize scientific/medical terminology and research theory in both oral and written communications.
• Ability to perform independent projects.
• Ability to network with and provide information to key groups and individuals, and work as part of a team.
• Knowledge of human subjects research, the regulations and policies surrounding it.
• Ability to represent the Cancer Center and its faculty in a professional manner.
• Ability to keep patient information confidential and possess knowledge of HIPPA regulations.

Hiring Range: $64,000 - $74,000, commensurate with education and experience.