Overview
The mission of the Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University (HNRCA) is to promote healthy aging through nutrition science to empower people seeking to enjoy long, active, and independent lives. HNRCA investigators examine how nutrition and physical activity play a role in the prevention of the major chronic degenerative conditions and diseases associated with aging.
Research nurses at the HNRCA are part of the Metabolic Research Unit (MRU), one of the center’s six scientific core units. The MRU facilitates and supports the clinical aspects of data collection with human study participants for the HNRCA's research teams. Research nurses and support staff implement research protocols and continually assess and monitor study participants. In addition to nursing services, the MRU provides participant recruitment and enrollment services, dietary and nutrition services from a metabolic kitchen, and study coordination.
What You'll Do
The senior research nurse is a registered professional nurse who manages the clinical course of research volunteers throughout a study. The primary function of the senior research nurse is to conduct human research protocols in a carefully monitored, controlled, yet dynamic environment. S/he utilizes the nursing process – assessment, planning, implementation, evaluation, and documentation – to ensure participant safety and data integrity. S/he oversees nursing operations for a team of registered nurses, nursing assistants, and phlebotomists; manages nursing workflow; and coordinates the nursing team’s efforts and work schedules through effective delegation of work assignments. The senior research nurse is responsible for knowledge of applicable Federal Regulations (45CFR46) and FDA Regulations (21CFR50, 56), policies and procedures of the Tufts Health Sciences Institutional Review Board (IRB), and all other guidance documents for the conduct of human clinical trials and human subject protection.
• Responsible for reviewing Tufts/USDA regulations governing conduct on Federal property (HNRCA building).
• Executes screening and intra-study informed consents for multiple studies in accordance with procedure approved by the Tufts Health Sciences IRB.
• Collects and documents participant health and research data in research record.
• Assesses for changes in participant health and eligibility status throughout study participation as well as compliance and tolerance.
• Recognizes, documents, and reports medical issues, abnormal laboratory values to study physician and tracks follow-up. Informs principal investigator (PI)/MRU medical director (MD)/study physician of pertinent clinical issues and adverse events.
• Administers investigational drugs, supplements, and test materials according to protocol and regulatory requirements.
• Implements regulatory requirements of the Tufts Health Sciences IRB and Good Clinical Practice.
• Uses the following nursing skills for data collection: phlebotomy, IV (insertion and line maintenance), volumetric infusion pump use, gastric tube placement and sampling, resting metabolic rates, EKG; assists with research procedures, e.g., fat biopsy, muscle biopsy, etc.
• Utilizes the nursing process to deliver professional nursing care.
• Conducts self in a competent and compassionate manner.
• Sets priorities using time and resources effectively.
• Initiates medical emergency system as needed.
• Implements regulatory requirements of the Tufts Health Sciences Institutional Review Board for Human Studies and Good Clinical Practice.
• Performs risk management assessment of protocol requirements to ensure volunteer safety.
• Implements, coordinates, and monitors the safe and accurate collection of protocol- specific clinical data on the MRU and occasionally offsite.
• Maintains a thorough knowledge of MRU protocols.
• Confirms Tufts Health Sciences Institutional Review Board approval of research protocols with principal investigators prior to study initiation; tracks modifications of protocols and subsequent Institutional Review Board approvals and communicates modifications of protocols to the nursing staff.
• Provides supervision and guidance to the MRU nursing staff regarding compliance with research protocols. Interprets and communicates research protocol requirements and takes necessary steps to clarify and/or resolve or issues pertaining to protocol execution.
• Ensures unit has supplies for ongoing studies and notifies relevant staff of ordering needs.
• Assists in development of study protocol budgets for nursing services.
• Develops, revises/updates data collection procedures based on regulations and guidance documents; determines and secures equipment and supplies (including pharmaceuticals).
• Documents and maintains all assigned study-related procedures, processes, and events.
• As protocol nurse, participates in protocol meetings and ongoing collaboration with the study team. Plans and designs study-specific forms and documents.
• Plans nursing staff study orientation and serves as a resource person for staff for assigned protocols.
• Safely and effectively delegates work assignments to achieve the accurate simultaneous execution of all protocol tasks, tests and data collection by the nursing team.
• Communicates all vital information to MRU manager and/or MRU MD as necessary for safe operation.
• Represents the nursing staff at MRU and HNRCA meetings.
• Assists investigators, study team members, and other departments to resolve immediate or time-sensitive concerns, issues, conflicts, or problems.
• Communicates and updates MRU Manager on operations and volunteer activity.
• Maintains skills in CPR and AED use.
• Maintains training and current certification in human subjects research ethics and regulations as required by the Tufts University Office of the Vice Provost for Research and the the Tufts Health Sciences Institutional Review Board.
• Maintains training as required for specific research protocols.
• Remains knowledgeable of the up-to-date HNRCA fire and safety procedures, biohazard, and radiation safety requirements.
• Participates in relevant professional development.
• May need to provide evening, weekend, and/or overnight coverage as indicated by protocol and unit needs.
What We're Looking For
Basic Requirements:
• Graduate of an accredited nursing program.
• Active Massachusetts Registered Nursing (RN) license in good standing
• IV and phlebotomy skills
• Clinical nursing experience in a hospital, clinic, or similar health care setting
• Proficient in Microsoft Office Word and Excel
• Completion of Human Research Participant Protection training within 2 weeks of start date
• CPR and AED certification within 2 weeks of start date
• Effective communication and organizational skills and good judgment
Preferred Qualifications:
• Experience in clinical research and working with research participants
• Experience working within IRB guidance and policies
• Experience with REDCap or other research data collection databases
Pay Range
Minimum $84,400.00, Midpoint $105,550.00, Maximum $126,700.00
Salary is based on related experience, expertise, and internal equity; generally, new hires can expect pay between the minimum and midpoint of the range.
