Clinical Research Coordinator NIH -

Cape Fox Facilities Services is seeking an experienced Clinical Research Coordinatortoindependently provide support services to satisfy the overall operational objectives of the National Cancer Institute. The primary objective is to provide services and deliverables through performance of support services.

Duties include:

• Supports clinical staff develop, implement and maintain clinical research data files and materials.
• Assist preparing and submitting for review accurate source documents related to all research procedures.
• Maintain and update files of all applicable regulatory documentation for Institutional Review Board (IRB).
• Participate in developing and maintaining research protocol documentation and operations.
• Assist researchers with study testing, observations data entry and other duties associated with study sessions.
• Collects research data and prepares information for inputs and analysis.
• Verify study participant information and collect data and results of testing.
• Assist staff develop, assemble related documentation and maintain regulatory binders for all protocols.
• Perform accurate and timely data analysis, report results and findings and respond to sponsor queries.
• Set up, format and enter data into spreadsheets to analyze information and create reports.
• Enter data into research databases, systems and applications for ongoing studies.
• Documents, collects, records, and retains all research related participant encounters including in person, phone, or electronic in the research record e.g., source documents, case report forms according to regulations, guidelines, and institutional specific policies, including ensuring good documentation practices for all documents
• Anticipate and consistently meet reporting deadlines, collaborating with PIs and teams to note data trends and identify problems
• Instruct data entry and clinical staff in procedures relative to data management, protocol instructions, Standard Operating Procedures and regulatory processes and considerations.
• Assists the research team with data extrapolation, entry, cleaning, and overall quality assurance of incoming and historical data
• Verifies study participant information and collects data longitudinally
• Supports the development of forms and questionnaires.
• Assist researchers develop, maintain and complete study data collection forms and source documents.
• Assist staff writing and editing clinical research protocols and informed consent forms (ICFs) based upon templates.
• Work with staff on the design, development and preparation of documents such as spreadsheets, letters, rosters, agendas, presentations and meeting minutes/summaries.
• Organize, prepare and distribute informational materials and provide support to the educational mission of the study to both the study team as well as participants
• Prepare materials, coordinate scheduling, track attendance and report results of workshops related research best practices, emerging trends in clinical studies, new literature and findings and regulatory considerations.
• Supports the collection of data from patient charts, medical records, interviews, questionnaires, and diagnostic tests.
• Retrieve research related information from medical records, hospital information system and laboratory information system and create spreadsheets and other reports for use in study analysis.
• Assist staff screen prospective study subjects and participate in scheduling participants for research visits and procedures.
• Assist researchers with the collection and analysis of research data and samples.
• Monitors subject's progress and reports adverse events.
• Observe data collection and monitoring of withdrawals and assist reporting deviations and adverse events.