University of Maryland, Baltimore (UMB) · 6 hours ago
Clinical Research Specialist
Baltimore, MD
Full-time
Onsite
Mid Level
$64K/yr - $70K/yr
3+ years expThe University of Maryland, Baltimore is seeking a Clinical Research Specialist to work in the Department of Diagnostic Radiology. This role involves coordinating clinical research activities, managing participant interactions, and ensuring compliance with research protocols.
BiotechnologyHealth Care
Responsibilities
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
Qualification
Required
Bachelor's degree in a scientific field of study related to the research of the clinical setting
Three (3) years clinical research including two (2) years in the relevant research specialization, preferably in Medicine, Surgery, Oncology or Radiology (cancer and/or vascular highly preferred)
Knowledge of position requirements
Knowledge of all applicable requirements, regulations, and laws
Skill in effective use of applicable technology/systems
Ability to effectively communicate both verbal and written thoughts, ideas, and facts
Ability to work cooperatively with others and independently
Ability to demonstrate, understand, apply, and adhere to the UMB Core Values of Respect and Integrity, Well-being and Sustainability, Equity and Justice, and Innovation and Discovery
Benefits
Comprehensive health insurance
Professional learning and development programs
Tuition remission for employees and their dependents at any University System of Maryland school
Generous PAID leave package that includes over 4 weeks of vacation accrued each year
16 paid holidays
3 personal leave days
Unlimited accrual of sick time
Company
University of Maryland, Baltimore (UMB)
The University of Maryland, Baltimore (UMB) was founded in 1807.
5001-10000 employees
Funding
Current Stage
Late StageLeadership Team
Scott Bitner
Vice President Finance & Auxiliary Services, Deputy CFO
Diane Forbes Berthoud, Ph.D.
Vice President and Chief Diversity Officer; Professor, Graduate School
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