Clinical Research Nurse I

Clinical Research Nurse I, is an entry level support title in the Clinical Research Nurse Family. 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 I, have no supervisory responsibilities and work under immediate supervision.

Assesses patients for protocol eligibility. Confers with study participants to explain purpose of study and obtains informed consent; explains diagnostic procedures and/or treatment plans to alleviate patient and/or family concerns; schedules patient for study procedures; initiates/coordinates drug orders, laboratory procedures and treatments for patients based on standing protocol orders. Collects data from patient charts, medical records, interviews, questionnaires, diagnostic tests and other sources; codes, evaluates and interprets collected data and prepares appropriate documentation; obtains blood samples, cultures, tissues and other specimens for laboratory analysis. Notifies Principal Investigator and supervisor of subject status.
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Attends Investigator meetings and conferences as required.
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Collects subject data, enters and analyzes data, and compiles reports, adhering to proper research protocols. Prepares documentation, reports, graphs, and other materials. Keeps appropriate logs, tracks participants, and prepares study materials.
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Performs physical exams, including assessing vital signs and administering prescribed medications. Obtains medical histories and conducts medical assessments of clinical trial subjects, including symptom management with appropriate referral. Creates treatment plans and serves as an information resource to trial subjects.
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Serves as Study Coordinator for pharmaceutical trials. Accurately reviews all study activities prior to activation; successfully arranges site initiation visits, monitoring visits, and close-out visits; disseminates new information to research staff, pharmacy staff, and principal investigator in a timely fashion. Ensures compliance with protocol guidelines and requirements of regulatory agencies; identifies problems and/or inconsistencies and monitor patients• progress to include documentation and reporting of adverse events; recommends corrective actions as appropriate.
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Supports regulatory staff submission of study protocols and amendments, consent forms, and recruiting materials to the Institutional Review Board and department for approval with oversight from supervisor.
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EDUCATION:

Required
Graduate of a School of Nursing. Associates Degree, Nursing
Preferred
Bachelor?s Degree, Nursing
BSN required or with approval of the hiring manager, experienced RN?s with an AD or Diploma with an active plan to obtain their BSN within four years from date of hire may be considered.

EXPERIENCE:

Required: Two years of clinical experience in related therapeutic area.

LICENSURE/CERTIFICATION/REGISTRY/LISTING:

REQUIRED
1. Technical skills related to the completion of a study visit as required by the protocol.
2. Computer Competency including proficiency in Microsoft Office and EDC systems
3. State of North Carolina nursing licensure is required
Obtain Good Clinical Practice certification within 30 days of hire and maintain without lapse.
Obtain Human Subjects Research certification within 30 days of hire and maintain without lapse.
PREFERRED
1. Understanding of ICH/GCP guidelines for human research
2. Understanding of Code of Federal Regulations for Human Subjects
3. Understanding Phases I-IV drug development processes
4. Clinical Research Coordinator (CCRC) and/or Clinical Research Associate (CCRA) is preferred.