Clinical Research Nurse - Human Nutrition Research Center on Aging

What You'll Do

This is 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 participants throughout a study. The primary function of the research nurse is to conduct human research protocols in a carefully monitored, controlled, yet dynamic environment to achieve quality outcomes for data and research participant safety to support the HNRCA research goals.

• Knowledge of Code of Federal Regulations and Good Clinical Practice, policies and procedures of the Tufts Medical Center/Tufts University Health Sciences Institutional Review Board and all other guidance documents for the conduct of human clinical trials and human research participant protection.
• Utilizes the nursing process—assessment, planning, implementation, evaluation, and documentation process to attain research participant safety and data integrity.
• Audits prospective research participants for study eligibility and conducts review of research participant health history for multiple studies.
• Admits research participants and obtains informed consents in accordance with procedures approved by the Tufts Medical Center/Tufts University Health Sciences Institutional Review Board.
• Reviews HNRCA/Tufts and USDA, building regulations and federal regulations governing conduct on federal property.
• Collaborates with multidisciplinary research team to coordinate study screening and enrollment; protocol treatment and follow-up care as needed.
• Audits changes in health and eligibility status throughout conduct of studies.
• Recognizes, documents and reports medical issues, abnormal laboratory values, and adverse events to study MD/PI and track follow-up.
• Delivers professional nursing care.
• Conducts self in a competent and compassionate manner.
• Initiates medical emergency system as needed.
• Responsible for accurate and complete documentation (written and electronic) in the research record for nursing-related data for each protocol.
• Follows HNRCA best practices for data collection, data retention and data QC procedures.
• Implements, coordinates and monitors the safe and accurate collection of protocol-specific clinical data on the MRU and occasionally offsite.
• Documents and maintains all assigned study-related procedures, processes and events.
• Utilizes and implements the use of computer technology to increase efficiency, improve data integrity and implement quality assurance measures during data collection and documentation.
• Develops, revises/updates data collection procedures and forms based on regulations and guidance documents; determines and secures equipment and supplies (to include pharmaceuticals).
• Implements regulatory requirements required by the Tufts Medical Center/Tufts University Health Sciences Institutional Review Board, CITI and Good Clinical Practice.
• Performs risk management assessment of protocol requirements to insure research participant safety.
• Maintains a thorough knowledge of MRU protocols and remains current on scientific developments as they pertain to development and implementation of research protocols.
• Confirms IRB approval of research protocols with principal investigators prior to study initiation; track modifications of protocols and subsequent IRB approvals, and communicate 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.
• Participates in protocol meetings and ongoing collaboration with the study team.
• Plans nursing staff study orientation and serves as a resource person for staff for assigned protocols.
• Sets priorities in consultation with supervisor using time and resources effectively.
• Performs and supports clinical research procedures and data collection activities, including but not limited to phlebotomy, IVs (insertion, sampling and maintenance), and EKGs, as well as other protocol-specific procedures.
• Assists with specialized procedures, including muscle biopsies, and monitors participants before, during, and after procedures in accordance with protocol and safety requirements.
• Performs clinical assessments and ongoing participant monitoring to ensure safety, protocol tolerance and compliance, and data integrity.
• Adapts to evolving research methodologies, procedures, and equipment to support a dynamic clinical research environment.
• Administers investigational substances in accordance with study protocols, institutional policies, and regulatory requirements.
• Maintains skills in CPR, AED and Human Protection Certification (CITI and GCP training).
• Remains current on HNRCA fire and safety procedures, biosafety and radiation safety requirements, and MRU and HNRCA trainings related to best practices and safety procedures related to clinical research and protection of research participants.
• Participates in professional development.

Basic Requirements

• Bachelor's Degree Graduate of an accredited nursing program.
• 2-3 years clinical nursing experience in a hospital, clinic, or similar health care setting.
• IV and phlebotomy skills.
• Completion of Human Research Participant Protection training within 2 weeks of start date.
• Active Massachusetts Registered Nursing (RN) license in good standing.

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.
• Effective communication and organization skills and good judgment are essential.