The Research Nurse has diverse responsibilities in support of clinical research, including soliciting, implementing, and managing clinical research projects. The Research Nurse is accountable for ensuring that clinical trials are conducted according to the sponsor's requirements, as well as institutional and governmental regulations. The Research Nurse performs administrative responsibilities requiring analysis, judgment, and knowledge of specific study protocols. Required clinical skills are similar to those of the RNs who are employed within NHRMC, and include the ability to assess and monitor the clinical status of the research participant, patient education, and appropriate referrals to medical or other clinical resources.
1. Works with physicians in soliciting clinical research studies.
2. Implements and manages clinical research studies.
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 consent form.
5. Provides the sponsoring organization with required documents.
6. Identifies protocol related needs and coordinates procedures with various departments.
7. Plans and conducts inservice education for personnel involved in the study.
8. Develops and arranges multimedia advertisements for patient recruitment and/or physician referrals (study specific).
9. Screens potential patients for recruitment.
10. Assesses patient/family educational needs with respect to the purpose and potential risks/benefits of study participation and standard cancer therapies; plans and implements patient/family education.
11. Assists the physician investigator 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.
14. Serves as liaison to Pharmacy in obtaining and dispensing appropriate drugs for study patients.
15. Maintains ongoing communication with the investigator to review participant progress/behavior, problems encountered, and adverse events.
16. Notifies the sponsor, the Regulatory Coordinator, the IRB (and others, as appropriate) of adverse events in accordance with federal regulations.
17. Serves as the central source of information on study activities.
18. Maintains the protocol manuals, investigational drug records, and patient shadow charts in an organized and accurate manner for easy retrieval and audit.
19. Follows HIPPA and hospital policy for releasing PHI; ensures source documents are redacted as appropriate to protect patient PHI and confidentiality.
20. Abstracts pertinent data from source documents and enters the data on the case report forms.
21. Ensures accurate documentation, data collection and record-keeping according to the sponsor's requirements, institutional, and governmental regulations.
22. Completes post participation follow-up on all research participants (i.e. letters of appreciation, communication with referring physicians, notification of study results).
23. Participates in quality improvement activities to ensure compliance with regulatory agencies, department and hospital policies and procedures.
24. Prepares for audits (FDA, Cooperative Groups, etc.) by obtaining & preparing necessary study files and documents; follows dept Quality Assurance guidelines
25. Assists in negotiating and managing certain financial aspects of specific studies, reconciling expenditures, and reporting to both the system and the sponsor.
26. Links study subjects and visits to research study in EMR; collaborates with finance coordinator for research billing compliance.
27. Utilizes database to generate reports and statistics; inputs accurate and timely data for designated study populations.
28. Serves as a liaison between the investigator, governmental agencies, pharmaceutical companies, funding agencies, study monitors, study participants, system personnel, and review boards (IRB, others).
29. Coordinates and performs patient assessments and patient care within the scope of licensure, credentialing & institutionally defined competency. Accurately observes, reports, and documents patient behavior and adverse reactions. Case manages designated study populations (patient/family/significant others) to ensure compliance with study requirements and optimum patient outcomes.
30. Continues personal development to enhance practice, profession and department effectiveness on an annual basis.
31. Performs other related duties as required.
32. Participates in the timely and efficient admission, transfer and discharge of patients.
* Registered Nurse
* Associate Degree
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 Nursing specialty 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.
Demonstrates standards of performance (ownership, teamwork, communication, compassion) that support patient satisfaction and principles of service excellence.
Performs other duties as assigned.
Individual will possess commensurate combination of education, experience and qualifications.