Nurse, Clinical Research

Role Summary

Nurse, Clinical Research responsible for supporting clinical studies by reviewing protocols and informed consent forms, ensuring protocol compliance, and participating in recruitment, data collection, and safety reporting. Collaborates with the Principal Investigator, study physicians, and study staff to execute study procedures in accordance with CFR, ICH GCP, and SOPs. Administers investigational drugs as needed, provides education to site staff, and develops source materials to ensure accurate documentation and compliance.

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 SOPs 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).

Qualifications

• For Recruiting & Screening: Minimum of a diploma from an accredited nursing school and 1-3 years work experience in a clinical research environment. For Unit: Bachelor of Nursing or other Science degree preferred with 1-3 years of nursing experience in a hospital setting; and/or ER/ICU experience
• Nursing competency skills per scope of practice (i.e., performing vital signs, nursing assessments, performing ECG/EKG, administering injections, etc.)
• Fundamental working knowledge of clinical research
• Advanced Life Support and Cardio-Pulmonary Resuscitation within six months
• Ability to organize and prioritize responsibilities while paying close attention to detail