Purpose:

The Clinical Research Nurse is a specialized research professional working with and under the direction of the clinical Principal Investigator (PI). Assists with the execution of study-related activities of a Phase I clinical research study. Research nurses should primarily be concerned with the protection and care of research subjects. The primary role is to function as a licensed registered nurse engaged in the practice of care/assessments of the healthy volunteers and/or patient. Position includes disseminating information regarding new information for documentation, performance improvement and data source upgrades.

Responsibilities

• 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’s 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).