Position Summary

The research nurse will identify eligible subjects for clinical trial enrollment, review consents, enroll subjects to clinical trials, manage the treatment, assess and report adverse events and discontinue patients from trial when appropriate, and follow subjects per protocol. The research nurse will collaborate with the research staff for all study related activities. The research nurse will work with direction from the principal investigators and the Administrative Director Cancer Center A research professional that interacts with study participants, physicians, clinical and administrative staff in the execution, conduct, and overall management of investigator initiated, National Cancer Institute (NCI) cooperative group, or industry sponsored clinical trials.

 Essential Functions and Responsibilities Includes the Following:

1. Coordinates all activities of ongoing clinical trials:
   • Obtains informed consent under supervision of the study investigator(s)
   • Screens patients for eligibility and registers subjects with sponsoring agency
   • Coordinates research team to ensure compliance with planned treatment protocol including required laboratory and radiographic testing
   • Procures, delivers, and ships blood and/or tissue samples, radiographs, and other clinical specimens as required by protocol
   • Acts as liaison between investigator(s) and sponsoring agency
   • Coordinates activities pertinent to the safeguarding of patients’ rights in research

1. Manages continuing medical care of research subjects:
   • Educates participants regarding study requirements, side effects, drug administration, etc.
   • Obtains and dispenses study drug
   • Performs toxicity assessments, phlebotomy, vital signs, EKGs as needed
   • Ensures adequate symptom management and provides best supportive care according to protocol

1. Manages study data of ongoing clinical trials, independently or in collaboration with  non-nurse research coordinators:
   • Ensures accurate and complete compilation of subject data through chart reviews
   • Collects and records study data on Case Report Forms and submits forms in a timely manner according to study guidelines
   • Meets with internal and sponsor appointed monitors to ensure accuracy of subject data and compliance with research protocol
   • Maintains source documents and subject files in accordance with White Plains Hospital (WPH) standard operating procedures (SOPs)
   • Analyzes data with investigators as needed

1. Ensures proper compliance with institutional and national regulatory requirements:
   • Reports adverse events and serious adverse events in accordance with WPH Institutional Review Board (IRB) SOPs, sponsor guidelines, and federal regulations

1. Performs other job related duties as required:

• • Participates in Investigators Meetings and coordinates Study Initiation Visits
  • Attends divisional/departmental/institutional educational and training seminars
  • Contacts local physicians to obtain source documentation and subject survival status
  • Performs all other related duties as assigned.

 Education & Experience Requirements

Graduate from an accredited school of nursing with current New York registration Bachelors of Science in Nursing is required. Experience working in a clinical research environment is strongly preferred.

Oncology Nurse Certification is preferred.

Clinical Research Certification (ACRP or SOCRA) is preferred.

Knowledge of current nursing, medical and health trends and practices in rendering of patient care. One year of acute care nursing experience preferred

BCLS certification is required.

 Core Competencies

Acts as a Professional Role Model Assessment Skills

Excellent Communication Skills (both verbal and written) Attention to Detail

Planning & Organizing

Sound Problem-Solving, Judgment and Decision-Making Skills Stress Tolerance

 Physical/Mental Demands/Requirements & Work Environment

May be exposed to chemicals necessary to perform required tasks. Any hazardous chemicals the employee may be exposed to arelisted in the hospital’s SDS (Safety Data Sheet) data base and may be accessed through the hospital’s Intranet site (Employee Tools/SDS Access). A copy of the SDS data base can also be found at the hospital switchboard, saved on a disc.

• • Position requires ability to move about freely at least 85 per cent of the time.
  • Must be able to remain stationary for extended/prolonged periods
  • Frequently moves/transports objects up to fifty (50) pounds and must be able to move patients of all weights with
  • a minimum of one (1) assist or assistive device/equipment
  • Must be able to work in environment with continuous interruptions
  • Must be able to assess and respond to rapidly changing situational needs of patients, department and hospital
  • Must be able to adapt in a high stress and fast-paced environment with multiple interruptions
  • Must be able to detect sounds and respond to emergency sounds/signals at all times
  • Must be able to constantly operate computer, equipment and other devices
  • Position requires ability to concentrate on fine detail with interruptions and attend to tasks for more than sixty (60) minutes at a time.
  • Individual must be able to understand and relate to theories behind several related concepts and remember multiple tasks given during the course of a day.

 Primary Population Served

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