Clinical Research Nurse - Human Nutrition Research Center Aging

Overview

The USDA-Human Nutrition Research on Aging (HNRCA) is one of six USDA human research centers created to study the effect of human nutrition on health. The HNRCA mission is to conduct state-of-the-art research on human nutrition and aging. The Metabolic Research Unit (MRU) is comprised of Volunteer Services, Nursing Services, and Dietary Services. The MRU’s Volunteer Services Division maintains a database from which they can recruit.

In addition, potential study participants are recruited for a variety of population, longitudinal, metabolic, and free‑living nutrition studies through use of social media, advertisements, and mailing lists. Research nurses and support staff implement research protocols and continually assess and monitor free‑living study participants. Registered dietitians and dietary support staff develop and implement the dietary component of research protocols, which includes strict feeding protocols created in the MRU research kitchen with careful food intake monitoring throughout the duration of each study.

All human research studies carried out in the MRU are reviewed and approved by the Tufts Medical Center and Tufts University Health Sciences Institutional Review Board (IRB).

This is a part‑time position at 21 hours per week. Salary is prorated based on the part‑time hours. This is also a grant‑funded position and is not eligible for severance pay.

The Clinical Research Nurse is a registered professional nurse, who manages the clinical course of research volunteers throughout a study. The primary function of the Clinical Research Nurse is to conduct human research protocols, in a carefully monitored, controlled, yet dynamic environment to achieve quality outcomes for data and volunteer safety to support the HNRCA research goals. The Clinical Research Nurse is responsible for knowledge of Federal Regulations (45

CFR
46) and the FDA Regulations (21

CFR
50, 56), policies and procedures of the TMC‑IRB, and all other guidance documents for the conduct of human clinical trials and human subject protection. The Clinical Research Nurse utilizes the nursing process—assessment, planning, implementation, evaluation and documentation—to attain volunteer safety and data integrity.

• Protocol Execution/data collection:
  • Responsible for assessing prospective volunteers for study eligibility and conducting review of subject health history for multiple studies. Responsible for reviewing HNRCA/Tufts and USDA, building regulations and federal regulations governing conduct on federal property.
  • Admits study subjects and obtains informed consents.
  • Executes intra‑study informed consents for multiple studies. Assesses changes in health and eligibility status throughout conduct of studies. Recognizes, documents and reports medical issues, abnormal laboratory values to study MD and tracks follow‑up. Notifies PI/MD of adverse events.
  • Administers investigational substances according to protocol and regulatory requirements. Uses the following nursing skills for data collection: phlebotomy, IV (insertions and maintenance), volumetric infusion pump use, gastric tube placement and sampling, resting metabolic rates, EKG, assists with protocol procedures e.g. fat biopsy, muscle biopsy, etc.
  • Assesses protocol tolerance and compliance.
  • Collects and documents participant health and research data.
  • Assesses subject future study eligibility status.
  • Delivers professional nursing care.
  • Conducts self in a competent and compassionate manner.
  • Sets priorities in consultation with supervisor using time and resources effectively.
  • Maintains and provides documentation (written and electronic) in the research record. Follows HNRCA best practices for data collection, data retention and data QC procedures.
  • Informs PI/MD of pertinent clinical issues and adverse events.
  • Initiates medical emergency system as needed.
  • May need to provide evening, weekend, and/or overnight coverage as indicated by protocol and unit needs.
• Protocol Development:
  • Implements regulatory requirements of the TMC Investigational Review Board for Human Studies and Good Clinical Practice.
  • Performs risk management assessment of protocol requirements to…