Research Nurse Coordinator

Research Nurse Coordinator - Open Rank Overview

Under the direction of the Principal Investigator or designee, the Research Nurse Coordinator is responsible to carry out all delegated tasks related to complex protocols testing investigational drugs, devices, or research interventions. The Research Nurse Coordinator is a primary resource for study protocol conduct acting as a liaison between the University of Massachusetts Medical School (UMMS), clinical partners (ex. University of Massachusetts Memorial Health Care (UMMHC)), the Principal Investigator, Institutional Review Board (IRB), and sponsors to ensure good clinical practice standards (GCP) throughout the life cycle of the study.

This is an open-rank posting (there are 3 levels of Research Nurse Coordinator) - candidates will be hired into the level commensurate with their experience.

• Review and abstract medical record information in a consistent manner, in accordance with study protocol, institutional, and HIPAA requirements
• In collaboration with the investigational pharmacy, ensure proper adherence to randomization schema, study drug dosing and administration per protocol
• Participate in quality assurance internal audits
• Screen patients according to study criteria, randomize, enroll, and consent in accordance with GCP standards
• Maintain patient/subject confidentiality and strictly adhere to all federal, state, and institutional standards for GCP
• Maintain business confidentiality as it relates to sponsor, protocol and related regulatory documents
• Perform nursing assessments of study participants according to protocol and consult with clinician or Principal Investigator as necessary
• Document and record, in writing or electronically, all study events and protocol related procedures
• Identify adverse events according to study standards; triage, report, and document with the Principal Investigator according to IRB and sponsor requirements
• Schedule, perform, and/or coordinate all study procedures according to protocol requirements and sponsor conventions
• Responsible for all regulatory paperwork in accordance with sponsor and institutional standards throughout the life of the study. Report findings to the Principal Investigator, sponsor, and IRB when necessary
• Review clinical system billing charges for accuracy and appropriateness
• Ensure that all required study event and protocol related data is accurately and efficiently entered into the clinical trial management system
• Attend meetings, conferences, seminars, and applicable training as required
• Ensure that all staff adhere to policies and procedures of any clinical site where study is being performed and adhere to all UMMS institutional health, safety, and infections control regulations and requirements
• Perform other duties as required

Duties noted above plus:

• Assist the Principal Investigator in feasibility and budget assessments for research studies, recommend changes and adjustments as necessary
• Responsible for the protocol specific training of the study team and clinical staff
• Assist in the development of research protocols, case report forms, and case report form completion guidelines
• Maintain and coordinate all aspects of complex study conduct, including data and source documentation, adverse event reporting, and communications with the IRB
• In collaboration with the Principal Investigator, assist in collation, writing, and editing of research results
• Provide feasibility assessment of research study protocol requirements and design a recruitment plan for assigned clinical studies
• Take primary responsibility for creation and maintenance of all regulatory documents, including initial IRB submission, continuing review submissions, and FDA and sponsor required regulatory documents
• Organize and maintain appropriate regulatory documents in accordance with sponsor and institutional standards throughout the life of the study
• Responsible for all regulatory paperwork and to report findings to the Principal Investigator, sponsor, and IRB when necessary

Duties noted above plus:

• Review new research protocols to assess feasibility
• Administ…