The Research Nurse has diverse responsibilities in support of clinical research, including soliciting, implementing, and managing daily clinical trial activities. The Research Nurse is accountable for ensuring that clinical trials are conducted according to the sponsor's requirements, as well as institutional policies and federal regulations. The Research Nurse performs tasks requiring analysis, judgment, and knowledge of specific study protocols and professional nursing care.
1. Works with physicians in soliciting clinical research studies. 2. Implements and manages the day-to-day operations for all clinical research activities and study subject care. 3. Maintains detailed knowledge of all components of study protocols. 4. Prepares reports for submission to the Institutional Review Board (IRB); assists with development of the study forms and reporting. 5. Provides the sponsoring organization with required documents; facilitates monitor visits. 6. Identifies protocol related needs and coordinates procedures with various departments. 7. Plans and conducts in-service education for personnel involved in the study. 8. Develops and arranges multimedia advertisements for patient recruitment. 9. Screens potential subjects for eligibility and recruitment. 10. Assesses patient/family educational needs with respect to the purpose and potential risks/benefits of study participation; plans and implements education accordingly. 11. Assists investigators in obtaining informed consent prior to initiation of any study related procedures. 12. Assumes technical responsibilities and/or makes arrangements for their completion as required by the study (i.e. specimen collection, medication administration, and special procedures). 13. Maintains and organizes research study supplies and prepares study kits for shipping biospecimens. 14. Serves as liaison between study investigators and pharmacy for investigational product including accountability. 15. Maintains ongoing communication with the investigator to review subject progress/behavior, problems encountered, and adverse events. 16. Notifies the sponsor, the regulatory coordinator, the IRB (and others, as appropriate) of adverse events and protocol deviations in a timely manner, and assists with documentation for reporting and CAPAs. 17. Serves as the central source/point of contact of information for study activities. 18. Maintains the protocol manuals, investigational product records, and patient shadow charts in an organized and accurate manner for easy retrieval and audit ready purposes. 19. Generates pertinent data from source documents and enters the data on the case report forms (paper and/or electronic). 20. Ensures accurate documentation, data collection and record-keeping according to the sponsor's requirements, and department guidelines. 21. Completes post participation follow-up as applicable (i.e. letters of appreciation, communication with referring physicians, notification of study results). 22. Participates in department quality improvement activities. 23. Prepares for audits by obtaining & preparing necessary study files and documents. 24. Assists with certain financial aspects of studies, such as subject stipends per informed consent; understands clinical trial billing and the importance of tracking and timely reporting. 25. Utilizes CTMS/database and inputs accurate and timely data for designated study subjects. 26. Serves as a liaison between the investigator, governmental agencies, pharmaceutical companies, funding agencies, study monitors, study subjects, system personnel, and review boards (IRB, others). 27. Coordinates and performs patient assessments and patient care within the scope of licensure, credentialing & institutionally defined competencies. 28. Plan, provide, supervise and document professional nursing care utilizing nursing process for patients in accordance with physician orders and institution policies and procedures. 29. May delegate tasks and supervise the activities of other licensed and unlicensed research staff. 30. Demonstrates standards of performance (ownership, teamwork, communication, compassion) that support patient satisfaction and principles of service excellence. 31. Performs all other duties as assigned.
1. Education/Licensure/Certifications: Associate Degree (or higher) in Nursing from an accredited school of nursing required. 2. Licensure: current license to practice professional nursing in the State of North Carolina required; certification in Oncology Nursing (ONS/OCN or ONS/AOCN) or research-related certifications (SOCRA/CCRP, ACRP/CCRA, ACRP/CCRC) is preferred. 3. Experience: 5 years experience in nursing; 1 year experience in clinical research preferred.