Clinical Lead Nurse (RN/CRCC)

A Clinical Lead Nurse (RN/CRCC) ensures that the assigned inpatient nursing activities are performed effectively and efficiently on a daily basis, monitors all relevant documentation, ensures that nursing staff competently follow clinical practices as they relate to the clinical research process, FDA regulations, DEA Regulations, Good Clinical Practices, OSHA guidelines and regulations, Institutional Review Board (IRB) regulations and sponsor commitment, and allocates resources to ensure proper coverage in inpatient unit.

Essential Job Functions:

  • Manages the nursing staff in the inpatient unit and ensures unit is properly staffed
  • Ensures nursing operational standards are met, with nursing staff following policies and procedure
  • Tracks and manages work outages and overtime worked
  • Manages the hiring, work-performance counseling, training, and competencies of nursing staff
  • Evaluates performance of staff as required
  • Assists in conducting research protocols in a manner that ensures patient/subject safety, quality, consistency, timelines, and accuracy
  • Ensures familiarity with the protocol, supplemental pharmacy/administration manuals, informed consent, source documentation, subject diary (when applicable), and study/concomitant medication for the assigned research study
  • Ensures knowledge of FDA regulations regarding Good Clinical Practices and applies them during conduct of the clinical trial
  • Maintains rapport with patient/subject, relatives/friends of patient/subject, Physicians, office staff and any other personnel involved in the conduct of the study
  • Performs protocol procedures as delegated by the Principal Investigator
  • Completes precise and timely progress notes (source documents) for study subjects as needed
  • Assists with maintenance of adequate inventory nursing-related medication/supplies needed to complete each study
  • Communicates on a regular basis with clinical site management and unit staff
  • Ensures that required nursing equipment is operating to sponsor, vendor, unit, and protocol specifications
  • Perform query and data clarification resolution as required
  • Other duties as reasonably assigned by the Unit Director

Knowledge, Education, and Experience:

  • Current NJ nursing license
  • Strong background as clinical research nurse
  • Knowledge of FDA, DEA and GCP requirements
  • OSHA and HIPPA training

 

Job Category: Patient Care

Job Type: Full Time

Job Location: BerlinMarlton

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