Clinical Research Senior Assistant or 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 Senior Clinical Research Assistant or Clinical Research Specialist (Senior Clinical Research Assistant or Clinical Research Specialist).

Following an extensive training program, the Bone Marrow Clinical Research Senior Assistant/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 Clinical Research Senior Assistant/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 Clinical Research Senior Assistant/Specialist is also responsible for data collection, resolving standard of care issues and direct research support.

The Bone Marrow Clinical Research Senior Assistant/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

UMB offers a comprehensive benefits package that prioritizes wellness, work/life balance, and professional development, along with additional exciting perks that employees can take advantage of. 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).

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 - Senior Clinical Research Assistant

• Responsible for facilitating and coordinating clinical research patient visits and data collection. Supports the conduct of clinical trials, including the coordination of start-up activities, scheduling and preparing for patient visits, assisting with data collection and clarification, and general administrative duties.
  
  
• Assists in 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. May assist in developing and recommending policies and procedures and/or design methods for clinical research activities.
  
  
• Coordinates data collection of the research study including obtaining medical records, lab results, diagnostic results, visit notes, etc. Coordinates recruitment and screening subjects for research studies according to IRB approved protocols. May communicate directly with study participants.
  
  
• Coordinates paperwork for submission of IRB protocol, IRB amendments, and IRB continuing reviews. Document and report all adverse events as appropriate.
  
  
• Participates in audits and monitor visits as needed according to policy.
  
  
• Performs the coordination of data analysis and interpretation, and develops statistical reports of study data using descriptive statistics using SAS, STATA, and SPSSS software. Assists in developing, submitting, and providing content for grants, papers, abstracts, manuscripts, and presentations. Conducts and analyzes literature searches. Develops and establishes a database to track research data.
  
  
• Coordinates development of research protocols and materials by providing study analysis and forming conclusions and recommendations.
  
  
• Documents in accordance with state and federal standards pertaining to specific research participant enrolled in the study. 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.
  
  
• Performs other duties as assigned.
  
  

Primary Duties - Clinical Research Specialist

• 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 and 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 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 ensures protocol compliance while participants are in a study.
  
  
• Serves as a 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.
  
  
• 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 invoices, developing policies, procedures, and/or methods for laboratory experimentation; and ordering supplies.
  
  
• Searches relevant literature, develops conclusions on research findings, writes reports, prepares and delivers 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 :

Minimum Qualifications - Senior Clinical Research Assistant
Education: Bachelor's degree in a scientific field of study related to the research of the clinical setting.
Experience: Two (2) years of experience in clinical research in research being performed in unit. Prior experience with patients and patient interaction preferred.
Other: May consider a combination of directly related experience and education. Some schedule flexibility may be required.

Minimum Qualifications - Clinical Research Specialist
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. Prior experience with patients and patient interaction preferred.
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.
  
  
• 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 the Senior Clinical Research Assistant is $54,000 - $60,000, commensurate with education and experience.

The Hiring Range for the Clinical Research Specialist is $62,000 - $73,000, 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 HRJobs@umaryland.edu.

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 HRDiversity@umaryland.edu. Please note that only inquiries concerning an ADA request for reasonable accommodation will be responded to from this email address.

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 UMB Notice of Non-Discrimination for more information.