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 compliance with Corporate, divisional, and departmental SOP鈥檚 and external (CFR, ICH GCP) regulatory guidelines. Responsible for compliance with applicable Corporate and Divisional Policies and Procedures.
Evaluate adverse events and manage safety reporting activities in a timely manner.
Interact with the Principal Investigator and other study physicians, Recruiting/Screening, Data Systems, and other personnel in support of study-specific activities.
Support quality and compliance improvement initiatives as appropriate.
Participate in the recruitment and screening activities to ensure successful enrollment of volunteers into studies scheduled at the Phase 1 Unit. Interfaces with research participants to support efforts to determine eligibility and consenting of study participants according to protocol. Review and assess data collected. Serve as a resource person or act as a consultant within area of clinical expertise (R/S).
Disburses investigational drug and provides teaching regarding administration, as necessary. Develops accurate source materials and ensures compliance from site staff. Ensures all protocol procedures are completed per study requirements (Unit).