Research Nurse II # 26-25977

Contract: 12 MonthsSchedule: Need to have night shift with some PM (8 hour or 12-hour shifts). Every other weekend availability (primarily weekend 22:45-07:15 or 18:45-07:15). For orientation must have the ability to dedicate approximately 6 weeks for all 3 shifts for trainingJob 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 ACPRU's 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)