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Job Summary:

The Research Nurse is responsible for conducting studies involving a wide variety of investigational products and various sponsors. This position works directly with a Physician Investigator ("PI") on clinical research performed within his/her area of interest.

Position Responsibilities:

Executes and manages all aspects of clinical trials working directly with Principal Investigators and Physicians.  Screens subjects for clinical trial eligibility and guides subjects through the informed consent process.

Participates in the conduct of audits by study sponsors, CROs, the FDA, Cooperative Groups, and others.

Coordinates activities of care team in caring for study subjects. Provides oversight of administration of medications. Develops and maintains ongoing communication with the clinical teams. Provides in-service education and support to infusion staff as appropriate. Provides ongoing service education updates to all investigators and staff that have eligible participants for clinical research trials.

Provides information and support for subjects and families regarding research trials participation and informed consent.

Review all clinical and laboratory data and adverse events, to the Principal Investigator (PI) for assessment and review, and communicate with medical staff regarding protocol-specific management of toxicities and adverse events.  Report adverse events as appropriate to study sponsor.

Collect, review and report timely, valid, accurate study data within the timelines specified by the Protocol and/or Clinical Trials Agreement..

Responsible for functional supervision of non-licensed personnel assigned to work with the nurse.  Represents Clinical Research Program on various leadership Committees as appropriate.

Position Qualifications Required:

Required Experience:

2-5 years of Nursing Experience, prior Clinical Research experience preferred. Excellent communication and interpersonal skills required to communicate with physicians and patients about the protocol requirements.

Required Education:

RN from an accredited School of Nursing.

Training / Certification / Licensure:

Current NJ RN License, BLS certification.  NIH Human Subjects Protection certification. CCRP, CCRC, or ACRP-CP eligible or certification preferred.  [Oncology Dept Only: One of the following CCRP, CCRC or ACRP-CP certification required within 18 months of hire or within 6 months of eligibility whichever comes first.]