Clinical Research Lead Specialist​/Contractual C2

Job Description

This is a FULL-TIME, CONTRACTUAL C2 position

University of Maryland, Baltimore (UMB) is currently seeking a Clinical Research Lead Specialist to join the Department of Radiation Oncology in the School of Medicine.

UMB offers a comprehensive benefits package that prioritizes wellness, work/life balance, and professional development. Contingent Category II staff receive a generous leave package that includes over 2 weeks of vacation each year, paid holidays, personal leave, sick time, and time for community service; subsidized comprehensive health insurance and supplemental retirement options; professional learning and development programs; limited tuition remission for employees enrolled at UMB;

life insurance and long-term disability; 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.

Employees whose job duties require them to work in clinical settings or at clinical or field sites continue to be subject to the vaccine requirements of those sites. This position is required to be vaccinated against COVID-19. For additional information on protocols and exemptions, please visit the COVID-19 website.

• Leads the highest technical research and guides research programs, projects, and activities in a clinical setting.
• Responsible for ensuring design, development, documentation and implementation of research procedures and protocols using a variety of complex activities. Networks with faculty and staff to achieve strategic goals and maximize efficiency.
• Develops, recommends, modifies, and implements policies and procedures and/or methods of clinical research to meet changing needs and requirements and enforces standards. Prepares for the Institutional Review Board (IRB) and Health Insurance Portability and Accountability Act (HIPPA) protocol development and ensures compliance of research operations with protocols. Coordinates developing and recommending policies and procedures and/or design methods for clinical research activities.
• Leads the management and analysis of clinical research data to include data analysis using statistical software, data collection, data entry, data verification, and ensures compliance and clinical relevance of data. Assists in the development and implementation of site tracking tools to comply with data monitoring requirements per federal regulations and guidance. Independently cleans, validates, and analyzes research data in order to prepare research findings for publications of journal articles and grant proposals.
• Leads the development of project timelines, work plan, recruitment strategy, and progress through the duration of the research study or clinical trial. Collaborates with Principal Investigators and regulatory staff in the preparation of new protocol submissions, protocol amendments, and renewals of ongoing clinical trial.
• Performs advanced 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.
• 'State' funds here mean tax payer dollars via the annual department State of Maryland budget. This position is funded by Department Revolving and UMBF Donor funds.
• 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 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 the management of day-to-day clinical research operations and leads study initiation, execution, and completion. Assists in the design and provides 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.
• Provides 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, developing policies, procedures, and/or methods for laboratory experimentation; and ordering supplies.
• Searches relevant literature, develops conclusions, writes reports, prepares, and delivers presentations of relevant findings and conclusions, and recommends appropriate actions. Reviews analysis and reports of less experienced members of the research team.
• Trains…