Research Registered Nurse
The Research Registered Nurse is responsible for safe and effective implementation of clinical trial protocols. The research nurse ensure that study protocols are conducted, documented, and reported in accordance with the study protocol, standard operating procedures, ICH-GCP, and all applicable regulatory requirements.
PRINCIPAL JOB FUNCTIONS :
- Commits to the mission, vision, beliefs and consistently demonstrates our core values.
- Recruits patients for clinical trials. Monitors and verifies subject eligibility for, and compliance with, protocols and monitors them in treatments, including long term follow-up.
- Assists with the preparation of IRB applications including protocol and informed consents and obtaining approval to conduct the study.
- Maintains appropriate correspondence with the IRB, including adverse events, annual renewals, and protocol amendments.
- Designs workflow procedures including study worksheets in accordance to study protocols and standard operating procedures.
- Conducts telephone and in-person interviews to determine subject eligibility. Schedules intake appointments to recruit subjects to study.
Obtains informed consent and HIPAA authorization, conduct intake interview, and enroll subjects.
- Maintains source documents and regulatory documentation of clinical trials. Ensures quality of data on case report forms.
- Monitors health and safety of subjects with frequent contact and ensure subject compliance with the study protocol.
- Presents adverse event documentation to the Principal Investigator and sponsor where appropriate.
- Provides information on studies to referring physicians and keeps them updated on their patients status.
- Creates and maintains database of subject information and generate reports and shipments of data to coordinating center as needed.
- Prepares documents for review by sponsors, monitors, and regulatory authorities as necessary.
- Participates in meetings with sponsors, monitors, and regulatory authorities as necessary.
- Follows all HIPAA requirements and maintains patient confidentiality.
EDUCATION AND EXPERIENCE :
Current Registered Nurse licensure from the State of Nebraska or approved compact state of residence as defined by the Nebraska Nurse Practice Act.
Bachelors degree preferred. Minimum two years of clinical experience preferably in cardiovascular care required. Experience in clinical research, study coordination, data management and study development is preferred.
Basic Life Support (BLS) required.