Clinical Research Nurses work closely with study subjects and other research staff and are involved in most steps of the research trial process. They perform some patient-related care and assessments within the scope of their licensure. Their work is routine in nature, with assignments provided at a task level, focused on the long-term goals of clinical research trial and process. Clinical Research Nurses have no supervisory responsibilities and work under immediate supervision.
Essential Job Function:
- Reviews patient cases, medical histories, and current treatment plans to effectively recruit and enroll potential research subjects that are actively engaged in the informed consent process.
- Supports the regulatory process in the submission of study protocols, consent forms, and recruiting materials to the Institutional Review Board and the department for approval, facilitating the regulatory compliance necessary for research projects in the hospital/medical group setting.
- Helps coordinate activities for multiple simultaneous clinical trials, managing various research tasks efficiently, ensuring optimal use of resources and executing research protocols in a timely manner.
- Serves as study coordinator for pharmaceutical and/or device trials, successfully coordinating site initiation visits, monitoring visits, and close-out visits, and ensuring adherence to protocol guidelines and regulatory requirements.
- Corresponds with healthcare teams, providers, outside research partners, and patients, ensuring clear communication and continuity of care for patients.
- Assists in collecting and Reviewing data specific to clinical research studies to ensure accuracy and reliability.
- Assists with the maintenance of records of patient interactions and clinical research interventions to ensure consistent and coordinated care, including collaborating with Investigator in assessment and management of Adverse Events.
- Completes clinical tasks within the scope of nursing license to meet patients' immediate needs as necessary.
- Coordinates patient care under direction of the Investigator and in accordance with the clinical trial protocol.
- Attends Investigator meetings and conferences as required.
- Performs other duties as assigned.
Education:
- Required: Associate' Degree in Nursing.
- Preferred: Bachelor's Degree in Nursing.
Experience:
- Required: 1 year as a Registered Nurse.
Licensure/Certification/Listing:
- Required: Registered Nurse license in North Carolina or a Compact state, Basic Life Support (BLS) or Cardiopulmonary resuscitation (CPR) through American Red Cross or AHA Healthcare Provider.