Clinical Research Nurse

at  Tufts University

Overview:
The mission of the Jean Mayer USDA-Human Nutrition Research Center on Aging (HNRCA) at Tufts is to promote healthy aging through nutrition science to empower people seeking to enjoy long, active, and independent lives. The HNRCA is one the largest research centers in the world studying nutrition and its relationship to healthy aging and physical activity. We are one of six centers supported by the USDA. The HNRCA investigators conduct some of the world’s most advanced studies on nutrition and aging making significant contributions to U.S. and international nutritional and physical activity recommendations, public policy, and clinical healthcare.
Research nurses at the HNRCA are part of The Metabolic Research Unit (MRU). The MRU is one of the six Scientific Core Units at the HNRCA directed toward facilitating and supporting 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 is comprised of participant recruitment and enrollment, nutrition services from our metabolic kitchen and study coordination services.
What You’ll Do:

THIS IS A PART-TIME POSITION AT 21 HOURS PER WEEK AND THE SALARY RANGE LISTED BELOW WILL BE PRORATED. THIS POSITION IS GRANT FUNDED 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 Clinical 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. The Clinical Research Nurse is responsible for 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. The Clinical Research Nurse utilizes the nursing process-assessment, planning, implementation, evaluation, and documentation process to attain research participant safety and data integrity.

• Responsible for assessing prospective research participants for study eligibility and conducting review of research participant health history for multiple studies.
• Admit research participants and obtain informed consents. Execute intra-study informed consents for multiple studies in accordance with procedures approved by the Tufts Medical Center/Tufts University Health Sciences Institutional Review Board. Responsible for reviewing 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
• Assess changes in health and eligibility status throughout conduct of studies. Recognize, document and report medical issues, abnormal laboratory values to study MD and track follow-up. Notify PI/MD of adverse events.
• Administer investigational substances according to protocol and regulatory requirements. Use 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, assist with protocol procedures e.g. fat biopsy, muscle biopsy, etc.
• Assess protocol tolerance and compliance.
• Collect and document participant health and research data.
• Deliver professional nursing care.
• Conduct self in a competent and compassionate manner.
• Inform PI/MD of pertinent clinical issues and adverse events.
• Initiate medical emergency system as needed.
• Responsible for accurate and complete record keeping for nursing-related data for each protocol. Maintain and provide documentation (written and electronic) in the research record.
• Follow HNRCA best practices for data collection, data retention and data QC procedures.
• Implement, coordinate and monitor the safe and accurate collection of protocol-specific clinical data on the MRU and occasionally offsite. Document and maintain all assigned study-related procedures, processes and events.
• Utilize and implement the use of computer technology to increase efficiency, improve data integrity and implement quality assurance measures during data collection and documentation.
• Develop, revise/update data collection procedures and form based on regulations and guidance documents; determine and secure equipment and supplies (to include pharmaceuticals).
• Implement regulatory requirements required by the Tufts Medical Center/Tufts University Health Sciences Institutional Review Board, CITI and Good Clinical Practice.
• Perform risk management assessment of protocol requirements to insure research participant safety.
• Maintain a thorough knowledge of MRU protocols and remain current on scientific developments as they pertain to development and implementation of research 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 of protocols to the nursing staff.
• Interpret and communicate research protocol requirements and take steps to clarify and/or resolve issues pertaining to protocol execution.
• Participate in protocol meetings and ongoing collaboration with the study team. Plan nursing staff study orientation and serves as a resource person for staff for assigned protocols.
• Set priorities in consultation with supervisor using time and resources effectively.
• Maintain skills in CPR, AED and Human Protection Certification (CITI and GCP training).
• Remain 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.
• Participate in professional development.

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.

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

SPECIAL WORK SCHEDULE REQUIREMENTS:

• The schedule for this role varies.

• Responsible for assessing prospective research participants for study eligibility and conducting review of research participant health history for multiple studies.
• Admit research participants and obtain informed consents. Execute intra-study informed consents for multiple studies in accordance with procedures approved by the Tufts Medical Center/Tufts University Health Sciences Institutional Review Board. Responsible for reviewing 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
• Assess changes in health and eligibility status throughout conduct of studies. Recognize, document and report medical issues, abnormal laboratory values to study MD and track follow-up. Notify PI/MD of adverse events.
• Administer investigational substances according to protocol and regulatory requirements. Use 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, assist with protocol procedures e.g. fat biopsy, muscle biopsy, etc.
• Assess protocol tolerance and compliance.
• Collect and document participant health and research data.
• Deliver professional nursing care.
• Conduct self in a competent and compassionate manner.
• Inform PI/MD of pertinent clinical issues and adverse events.
• Initiate medical emergency system as needed.
• Responsible for accurate and complete record keeping for nursing-related data for each protocol. Maintain and provide documentation (written and electronic) in the research record.
• Follow HNRCA best practices for data collection, data retention and data QC procedures.
• Implement, coordinate and monitor the safe and accurate collection of protocol-specific clinical data on the MRU and occasionally offsite. Document and maintain all assigned study-related procedures, processes and events.
• Utilize and implement the use of computer technology to increase efficiency, improve data integrity and implement quality assurance measures during data collection and documentation.
• Develop, revise/update data collection procedures and form based on regulations and guidance documents; determine and secure equipment and supplies (to include pharmaceuticals).
• Implement regulatory requirements required by the Tufts Medical Center/Tufts University Health Sciences Institutional Review Board, CITI and Good Clinical Practice.
• Perform risk management assessment of protocol requirements to insure research participant safety.
• Maintain a thorough knowledge of MRU protocols and remain current on scientific developments as they pertain to development and implementation of research 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 of protocols to the nursing staff.
• Interpret and communicate research protocol requirements and take steps to clarify and/or resolve issues pertaining to protocol execution.
• Participate in protocol meetings and ongoing collaboration with the study team. Plan nursing staff study orientation and serves as a resource person for staff for assigned protocols.
• Set priorities in consultation with supervisor using time and resources effectively.
• Maintain skills in CPR, AED and Human Protection Certification (CITI and GCP training).
• Remain 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.
• Participate in professional development