Research Nurse Specialist II – Part Time – Allergy – Pulmonary & Critical Care Medicine

Research Nurse Specialist II – Part Time – Allergy – Pulmonary & Critical Care Medicine

Requirements

• Knowledge and understanding of policies, procedures, and regulations governing human subject’s research and incorporation of them in the conduct of research and care of participants.
• Possesses a basic awareness of the Federal regulations governing the protection of human subjects, e.g., FDA, OHRP, GCP/ICH guidelines, and HIPAA regulations.
• Proficiently prepares and processes new IRB research proposals, amendments, continuing review applications and adverse events according to institutional and departmental policies and procedures and federal regulations.
• Possesses a basic awareness of the Vanderbilt policies and regulations governing the protection of human subjects.
• Knowledge and understanding of the management and implementation of clinical trial operations.
• Understanding and capability to perform the procedures required of each study protocol (obtains training needed to safely and accurately perform or assess required procedures).
• Utilizes nursing skills and processes to identify participant and study problems and utilizes problem solving skills to identify solutions, following through to implement solutions, and assuring goals are met.

Responsibilities

• Plans and implements recruitment procedures for potential participants, manages enrollment of the trial from screening to randomization to study completion, ensures compliance with protocols and overall research and clinical objectives.
• Maintains accurate and timely documentation and maintains communication with the sponsor.
• Participates in periodic site visits from sponsor, regulatory authorities and others to review research, source documentation and research procedures.
• Participates in the determination of eligibility and recruits candidates for study participation.
• Troubleshoots trial recruitment strategies to ensure trials are completed in a timely manner through implementing effective screening and recruitment strategies and completing required documentation.
• Provides education and training to appropriate personnel and participants in research specific methodology and procedures.
• Maintains open and positive communications with investigators, participants, co-workers, other departments and sponsors.
• Digests complex clinical information to determine if documentation is accurate, complete, and to ensure procedures contain appropriate safeguards.
• Proactively involved in quality improvement through ongoing assessment and through the identification of issues, and planning and evaluation of quality improvements.

Preferred Qualifications

No preferred qualifications provided.