Participate in the 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 departmental SOPs 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 studyspecific nursing activities.
Participate in quality and compliance improvement initiatives and provide feedback as appropriate.
Maintain accurate and complete source data in ACPRUs 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).
Requirements:
Bachelors/associates in nursing.
ICU is preferred telemetry or emergency room experience.
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