Clinical Research Specialist - Baltimore, United States - University of Maryland, Baltimore

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 Hematologic Malignancies research program. This position will be patient facing and responsible for implementing clinical research protocols on behalf of the faculty/principal investigator. The Clinical Research Specialist is the primary interface, along with the faculty member for cancer patients enrolled in clinical trials and will be responsible for screening, consenting, and enrolling the patients. Once a patient is enrolled, the Clinical Research Specialist will be responsible for guiding a patient through their courses of treatment, research visits, data collection, standard of care issues and direct research support. This position works directly with the medical care team, ancillary hospital staff, the Sponsor, and data managers within the Cancer Center. This full-time position works Monday through Friday and may require flexibility to work outside of normal working hours.

UMB offers a comprehensive benefits package that 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).

All University of Maryland, Baltimore (UMB) employees are strongly encouraged to follow all CDC recommendations related to COVID-19 vaccinations and booster doses. UMB's COVID-19 policy states that employees whose job duties require them to work in clinical settings or at field sites where the COVID-19 vaccination is required must adhere to those protocols. This position has been identified as one which requires the COVID-19 vaccination. For additional information on protocols and exemptions, please visit the COVID−19 website.

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.

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.
Other: May consider a combination of directly related experience and education. Some schedule flexibility may be required.

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.
• Prior experience with patients and patient interaction.
• 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.

The Hiring Range for this position is in the mid $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. For assistance related to employment, please contact the Staffing department at

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 a UMB Job Applicant Accommodation Request . You may also contact Please note that only inquiries concerning an ADA request for reasonable accommodation will be responded to from this email address.

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