Clinical Research Nurse - Human Nutrition Research Center Aging

Clinical Research Nurse – Human Nutrition Research Center on Aging, Tufts University, Boston, MA

Type:
Adjunct/Part-Time | Salary: $79,600 – $119,500 per year

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) comprises Volunteer Services, Nursing Services, and Dietary Services. The MRU’s Volunteer Services Division maintains a database from which volunteers are recruited. Potential study participants are recruited for a variety of population, longitudinal, metabolic, and free‑living nutrition studies through 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, 21‑hour per week position. It is grant‑funded and 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.

• Assess prospective volunteers for study eligibility and review subject health history for multiple studies.
• Review HNRCA/Tufts and USDA building regulations and federal regulations governing conduct on federal property.
• Admit study subjects and obtain informed consent.
• Execute intra‑study informed consents for multiple studies.
• Assess changes in health and eligibility status throughout the conduct of studies.
• Recognize, document, and report medical issues and abnormal laboratory values to the study MD and track follow‑up.
• Notify PI/MD of adverse events.
• Administer investigational substances according to protocol and regulatory requirements.
• Use nursing skills for data collection, including phlebotomy, IV insertion and maintenance, volumetric infusion pump use, gastric tube placement and sampling, resting metabolic rates, EKG, and assistance with protocol procedures such as fat biopsy and muscle biopsy.
• Assess protocol tolerance and compliance.
• Collect and document participant health and research data.
• Assess subject future study eligibility status.
• Deliver professional nursing care.
• Conduct self in a competent and compassionate manner.
• Set priorities in consultation with supervisor, using time and resources effectively.
• Maintain and provide documentation (written and electronic) in the research record.
• Follow HNRCA best practices for data collection, data retention, and data QC procedures.
• Inform PI/MD of pertinent clinical issues and adverse events.
• Initiate the medical emergency system as needed.
• May need to provide evening, weekend, and/or overnight coverage as indicated by protocol and unit needs.

• Implement regulatory requirements of the TMC Investigational Review Board for Human Studies and Good Clinical Practice.
• Perform risk management assessment of protocol requirements to ensure…