RN Clinical Research Nurse
Overview
Clinical Research Nurse II, is a title for experienced professionals in the Clinical Research Nurse Family. Clinical Research Nurses II, perform a full range of clinical research duties and have a working knowledge of the clinical research process and the regulations that govern it.
As licensed professionals, they perform patient related care independently, including medical assessments, symptom management, and referrals, within the scope of their licensure.
They perform progressively more complex and comprehensive clinical research duties at an ever-increasing level of independence, working closely with the Principal Investigator.
They work under supervision, but with more autonomy than a Clinical Research Nurse I, and may supervise some staff.
Talent Pool : Nursing
Responsibilities
Assists Principal Investigator in developing clinical trial protocols, and submits the required documentation to the Institutional Review Board, Cone Health, and corporate or government sponsors.
Conducts literature searches, correlates research material, and assists in writing scientific articles and papers. Coordinates multiple clinical trials simultaneously or clinical trials with unique complexity.
May supervise support staff or lower-level Clinical Research Nurses. Supports the orientation and training of new research team members and other staff.
Performs all duties of the Clinical Research Nurse I
Qualifications
EDUCATION : RequiredBSN required, or with approval of the hiring manager, experienced RN?s with an ADN or Diploma with an active plan to obtain their BSN within four years from date of hire may be considered.Preferred
EXPERIENCE : Required : Three years of clinical research experience is required (related graduate degree may substitute for two years of experience)Preferred : Two years of clinical experience in related therapeutic area.
LICENSURE / CERTIFICATION / REGISTRY / LISTING : REQUIREDRequired : RN Registered Nurse licensed in North Carolina or a Compact stateObtain 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.PREFERRED1. Understanding of ICH / GCP guidelines for human research2.
Understanding of Code of Federal Regulations for Human Subjects3. Computer Competency including proficiency in Microsoft Office and EDC systems 4.
Understanding Phases I-IV drug development processes5. Technical skills related to the completion of a study visit as required by the protocol.
6. Clinical Research Coordinator (CCRC) and / or Clinical Research Associate (CCRA) is preferred.
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