Clinical Research Nurse - Human Nutrition Research Center on 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).

What You'll Do

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 (45CFR46) and the FDA Regulations (21CFR50, 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 (insertion 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.
• Perform risk management assessment of protocol requirements to insure 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 IRB approval of research protocols with principal investigators prior to study initiation; tracks modifications of protocols and subsequent IRB approvals, and communicates modifications of protocols to the nursing staff.
• Interprets and communicates research protocol requirements and takes steps to clarify and/ or resolve issues pertaining to protocol execution.
• Oversees the administration of informed consent to human subjects in accordance with procedure approved by the Tufts University Medical Center IRB.
• Develops, revises/updates data collection procedures based on regulations and guidance documents; determines and secures equipment and supplies (to include 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 all study- specific forms and documents. Plans nursing staff study orientation and serves as a resource person for staff for assigned protocols.
• Maintains skills in CPR, AED and Human Protection Certification.
• Also is knowledgeable of the HNRCA fire and safety procedures, biohazard and radiation safety requirements.
• Participates in professional development.

What We're Looking For

Basic Requirements:

Knowledge and experience typically acquired by:

• Graduate of an accredited nursing program.
• Three to five years of acute clinical experience
• Proficient with Microsoft Office software suite, email, web search.
• Must be willing to attend external IV training within the first year of employment
• Ability to 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 2 weeks of hire.
• Ability to lift 25lbs with or without accommodations.
• Ability to 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

Salary is based on related experience, expertise, and internal equity; generally, new hires can expect pay between the minimum and midpoint of the range.