Job Description

• Participate in the execution of protocol activities of a Phase I clinical research study conducted at the Phase 1 Unit.
• Maintain safety and confidentiality of study subjects throughout the study
• Evaluate adverse events and manage safety reporting activities in a timely manner.
• Review protocols and informed consent forms for scheduled studies, identify, and communicate potential issues to the appropriate personnel.
• Participate in nursing study related activities as required by protocol in compliance with corporate, divisional, and depart-mental SOP's and external (CFR, ICH, GCP) regulatory guidelines.
• Communicate with the Principal Investigator and other study physicians, Recruiting/Screening, Data Systems, and other personnel to organize study-specific nursing activities.
  Participate in quality and compliance improvement initiatives and provide feedback as appropriate.
• Maintain accurate and complete source data in site eSource and/or other source documents and facilitate the resolution of source discrepancies or issues, as appropriate.
  Facilitate training of new nursing personnel and ensure management is apprised of trainee progress.
• Participate independently in the recruitment and screening activities to ensure appropriate enrollment of subjects into studies scheduled at the Phase 1 Unit. *
  Must have nursing skills (Start IVs, computer, dressings, assessment skills to name a few)

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