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OVERVIEW / POSITION DESCRIPTION

The AMCR Institute is a cutting-edge research institute specializing in the execution of Phase I-IV diabetes device and biopharmaceutical trials. Eligible subjects are offered the latest treatment options carried out under the strict guidelines from the Food and Drug Administration (FDA). Research subjects (Volunteers) become the most critical link in a chain of research and testing to develop breakthrough treatments for a broad range of health problems including Type 1 and Type 2 Diabetes. At all times the safety and confidentiality are guarded with the utmost concern.

As a member of AMCR Institute, you will contribute to the development of novel therapies and supportive technology for people with diabetes and be part of the discovery of new treatments.

The Clinical Research Nurse (RN) is a licensed clinical professional working with and under the direction of the Principal Investigator, Assistant Director, Lead Research Nurse, and in close conjunction with the Clinical Project Manager on early or late phase clinical trials related to the treatment of diabetes. The Clinical Research Nurse is an integral member of the clinical trial team and assumes responsibility and accountability for the direct research care of a group of research subjects during a designated time frame. The Clinical Research Nurse is responsible for assuring compliance with the Federal and State regulations relating to research and the study protocol requirements.

MATERIALS AND EQUIPMENT DIRECTLY USED

1. Phlebotomy and IV supplies including infusion pumps
2. Office equipment such as personal computer, printer and copier, telephone, fax
3. Diabetes-related medical devices (e.g. glucometer, insulin delivery devices, etc.)

INTERRELATIONSHIPS

Physicians, Nurse Practitioners, Physician Assistants, Nurses, Research Staff, Research Subjects, and Clinical Office and Administrative Staff

DUTIES AND RESPONSIBILITIES

Research / Regulatory:

1. Contributes to data collection by adhering to "Good Documentation Practices"
2. Documents in detail the data obtained following AMCR Institute's Standard Operating Procedure (SOP).
3. Competently recognizes signs and symptoms of Hypoglycemia, Hyperglycemia, and Ketosis and alerts the lead coordinator and clinician.
4. Working knowledge of research protocol to understand the science behind the study.
5. Assists research staff in specimen processing: spinning, pipetting, and analyzing using the YSI glucose instrument.
6. Discharge research subject upon completion of in-clinic visit following the "Glycemic Discharge Protocol for AMCR Institute".

Clinical:

1. Conducts a centered research subject assessment focusing on safety and venous access placement.
2. Using aseptic technique, identifies the largest accessible vein and starts intravenous placement (IV) on adults and pediatric research subjects. Number of IV lines depending on the research design. May place two (2) IV lines on the same arm and/or another line on the opposite arm. 
3. Using aseptic technique, changes IV bags PRN and adjust infusion pumps flow rate.
4. Employs strategies in maintaining subject's safety: monitoring heating pad temperature, awareness of blood glucose levels, phlebitis.
5. Administers research drugs and/or medications as ordered by a clinician.
6. Using aseptic technique, assists research staff in blood drawing using a 3-way stopcock method.
7. Assists research staff with performing vital signs and EKG tracings.
8. Provides the tools and necessary support to subjects in learning their diabetes management responsibilities in accordance with the protocol.
9. Provides nursing support to staff regarding diabetes issues as needed.
10. Organizes and prioritizes workload to effectively accomplish goals.         

Communication

1. Communicates clearly and effectively with clinicians, nursing and research staff, and research subjects.
2. Check-in and report with the Lead Research Coordinator and/or RN at the start and end of each shift and provide a complete outgoing report.
3. Sign / initial / and date all documents that were worked on during shift prior to leaving.

SCHEDULE

Shift availability varies depending upon the type and number of active research protocols being executed. Shift may range from 4 to 12 hours. Some flexibility may be possible depending upon the protocol. RNs are strongly encouraged to attend monthly meetings led by the Lead Research Nurse. These meetings may include protocol and skills training, updates, and other topics as needed.