Clinical Research Nurse - Human Nutrition Research Center on 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 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) 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). What You’ll Do 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. Protocol Execution / Data Collection 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. Protocol Development 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 volunteer safety. Coordinate and monitor the safe and accurate collection of protocol‑specific clinical data on the MRU and occasionally off‑site. Maintain a thorough knowledge of MRU protocols. Confirm IRB approval of research protocols with principal investigators prior to study initiation; track modifications of protocols and subsequent IRB approvals, and communicate modifications to the nursing staff. Interpret and communicate research protocol requirements and clarify or resolve issues pertaining to protocol execution. Oversee the administration of informed consent to human subjects in accordance with procedures approved by the Tufts University Medical Center IRB. Develop, revise, and update data collection procedures based on regulations and guidance documents; determine and secure equipment and supplies (including pharmaceuticals). Document and maintain all assigned study‑related procedures, processes, and events. Participate as protocol nurse in protocol meetings and ongoing collaboration with the study team. Plan and design all study‑specific forms and documents. Plan nursing staff study orientation and serve as a resource person for staff for assigned protocols. Maintain skills in CPR, AED, and Human Protection Certification. Be knowledgeable of the HNRCA fire and safety procedures, biohazard, and radiation safety requirements. Participate in professional development. What We’re Looking For Basic Requirements Graduate of an accredited nursing program. Three to five years of acute clinical experience. Proficient with Microsoft Office software suite, email, and web search. Must be willing to attend external IV training within the first year of employment. Complete CITI and NIH GCP training in the protection of human research subjects (required prior to interacting with human subjects), CPR and AED certification within two weeks of hire. Ability to lift 25 lbs with or without accommodations. Maintain professional and technical knowledge. Must be a licensed Massachusetts Registered Nurse and maintain current licensure to practice. Preferred Qualifications Experience in clinical research. IV and phlebotomy skills and experience. Ability to learn and utilize new software and database programs, including REDCap for electronic data capture. Demonstrated ability to work with a diverse multicultural group of study subjects and colleagues. Ability to work effectively in a team environment. Pay Range Minimum $79,600.00, Midpoint $99,600.00, Maximum $119,500.00 Additional Information Tufts is an affirmative action/equal opportunity employer and actively seeks candidates from diverse backgrounds. #J-18808-Ljbffr