Clinical Research Coordinator

Work Location

IC: NINDS

Street: 10 Center Dr

Bldg: 10

Room: 2B51B

City
:
Bethesda

State & Zip
: MD 20814

Work Hours

Weekly Hours

FT: 30-40 hours per week

# Of Hours

40

Overall Position Summary and Objectives

The primary role for this Research Coordinator (RC) position is to provide clinical research coordination through the NINDS Clinical Trials Unit (CTU) for the NINDS Intramural Research Program, including specific groups as assigned.

Bachelor's

3

• Clinical Research Associate (CRA)

• Miscellaneous Health Medical Professions
  - Nursing
  - Community and Public Health
  - General Medical and Health Services
  - Neuroscience Miscellaneous Biology
  - Cognitive Science and Biopsychology
  - Biology
• Genetics
  - Health and Medical Preparatory Programs
  - Nutrition Sciences
  - Pharmacy Pharmaceutical Sciences and Administration Treatment Therapy Professions
  - Communication Disorders Sciences and Services
  - Sociology
  - Miscellaneous Social Sciences
  - Interdisciplinary Social Sciences
  - General Social Sciences
  - Miscellaneous Psychology
  - Clinical Psychology
  - Psychology
  - Social Psychology
  - Social Work Chemistry
  - Multi-Disciplinary or General Science

• Clinical Trial Management System (CTMS)
• Electronic Medical Records System
• Electronic Data Capture System

• Overseeing and documenting IP dispensing, inventory and reconciliation
• Closing clinical trial sites down on completion of clinical trial
• Ordering, tracking, and managing IP and trial materials
• Implementation of clinical trial site action plans
• Training clinical trial site staff
• Coordinating project meetings
• Previous clinical trial work
• Electronic medical records
• Protocol review revision
• Phase I or II experience
• Patient confidentiality
• Remote site monitoring
• Regulatory compliance Protocol development
• Good Clinical Practice (GCP) knowledge
• Protocol writing
• Clinical Trials
• Data Monitoring
• Data Integrity
• Patient care
• Recruitment Scheduling
• Screening
• Research
• ICH/GCP
• SOPs

• Assist preparing and submitting for review accurate source documents related to all research procedures
• Assists clinical and research staff ensure that Case Report Forms CRFs are completed and document changes in research participant condition; adverse events; concomitant medication use; protocol compliance; response to study drug; and other required fields
• 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
• Maintains all professional licenses and certifications, if applicable
• Maintain a current clinical trial and clinical research study Good Clinical Practice GCP knowledge base, in order to serve as an expert resource to the client in a regularly changing field, and addresses identified knowledge and skill gaps related to role

• 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

• 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
• Review draft protocols, case report forms, and manuals of operations for clarity, and completeness
• Work with staff on the design, development and preparation of documents such as spreadsheets, letters, rosters, agendas, presentations and meeting minutes summaries
• Assist…