Clinical Research Nurse

Clinical Research Nurse

Secaucus, NJ

Position title

Clinical Research Nurse
Reports to: Clinical Operation Director

Duties

Responsible for working under the guidance of Frontage Medical Director; Principal Investigator and Sub-Investigators; Clinical Operation Director, CRC Operations; and Clinical Research Coordinators to perform study procedures required in clinical research studies conducted on behalf of sponsors at Frontage Supervises: Laboratory Technicians and Medical Assistants (functional supervising responsibility).

Qualifications

  • An active Registered Nurse (RN) or LPN license in the State of New Jersey American Heart Association – Basic Life Support
  • Certificate Experience: A desired candidate will have minimum of 1 year experience in clinical research
  • Recent nurse graduate is acceptable and will provide on-job training
  • A knowledge of FDA regulatory requirements and GCP for clinical research
  • Team work, good communication skills, and detail oriented. Computer skills

Specific Responsibilities

  • Screens study subjects for eligibility for inclusion into the studies; Provide direct care to research subjects, including drug administration, lab draws, coordination of appointments, follow-up and management of side effects under the guidance of PI, etc.
  • Develops a high level of familiarity and knowledge of the study protocol and flow chart of study procedures
  • Develops a strategy for implementing study procedures in compliance with the study protocol
  • Performs study procedures (e.g., start intravenous lines, venipunctures, obtain biological specimen samples, obtain ECG recordings, vital signs, safety assessments, etc.) as required by study protocol under the supervision of the Clinical Research Coordinator, Principal Investigator, and Sub-Investigators
  • Records study data in the source documents
  • Evaluates and reviews study data to ensure accuracy and completeness
  • Assists the Clinical Research Coordinator in transcribing study data from source documents to sponsor designated case report forms or records data for remote data entry if applicable
  • Resolves data queries in conjunction with the sponsor
  • Assists the Principal Investigator with gathering and recording relevant data for adverse event reporting and expedited reporting of serious adverse events to the sponsor
  • Responsible for maintaining emergency medication in the crash cart and regular maintenance of AEDs and defibrillators
  • Assist pharmacist in test article preparation, dispensing, and dosing
  • Carries out verbal or written Medical Orders (e.g., dose concomitant medications, closely monitor subject’s vital signs) as requested by the Investigator
  • Performs other duties as assigned

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