Research Nurse Coordinator

Position Summary

Under the direction of the Principal Investigator or designee, the Research Nurse Coordinator is responsible for carrying out all delegated tasks related to complex protocols testing investigational drugs, devices, or research interventions. The Coordinator serves as the primary liaison between the University of Massachusetts Medical School (UMMS), clinical partners (e.g., University of Massachusetts Memorial Health Care (UMMHC)), the Principal Investigator, Institutional Review Board (IRB), and sponsors to ensure Good Clinical Practice (GCP) standards throughout the study life cycle.

This is an open‑rank posting, with three levels of Research Nurse Coordinator. Candidates will be hired into the level commensurate with their experience.

• Review and abstract medical record information consistently in accordance with study protocol, institutional, and HIPAA requirements.
• Collaborate with the investigational pharmacy to ensure 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 obtain consent in compliance with GCP standards.
• Maintain patient confidentiality and adhere to federal, state, and institutional GCP standards.
• Maintain business confidentiality regarding sponsor, protocol, and regulatory documents.
• Perform nursing assessments per protocol and consult with clinician or Principal Investigator as necessary.
• Document all study events and protocol‑related procedures in writing or electronically.
• Identify, triage, report, and document adverse events per study standards and sponsor/IRB requirements.
• Schedule, perform, and/or coordinate all study procedures according to protocol requirements.
• Handle all regulatory paperwork in accordance with sponsor and institutional standards throughout the study life cycle.
• Review clinical system billing charges for accuracy and appropriateness.
• Enter all required study event and protocol‑related data accurately into the clinical trial management system.
• Attend meetings, conferences, seminars, and applicable training as required.
• Ensure staff adherence to policies and procedures of any clinical site where the study is performed and comply with UMMS institutional health, safety, and infection control regulations.
• Perform other duties as required.

• All responsibilities of RNC I.
• Assist the Principal Investigator in feasibility and budget assessments, recommending changes as necessary.
• Provide protocol‑specific training of the study team and clinical staff.
• Assist in developing research protocols, case report forms, and completion guidelines.
• Maintain and coordinate all aspects of complex study conduct, including data and source documentation, adverse event reporting, and communication with the IRB.
• Assist in collating, writing, and editing of research results.
• Provide feasibility assessment of research study protocol requirements and design a recruitment plan.
• Take primary responsibility for creation and maintenance of all regulatory documents, including initial IRB submission, continuing review submissions, and FDA/sponsor requirements.
• Organize and maintain appropriate regulatory documents in accordance with sponsor and institutional standards throughout the study life cycle.
• Report findings to the Principal Investigator, sponsor, and IRB as required.

• All responsibilities of RNC I and II.
• Review new research protocols to assess feasibility.
• Administratively responsible for recruiting, screening, assigning, monitoring, maintaining, and terminating study subjects.
• Communicate with outside vendors to secure services required by the research protocol.
• Assume administrative responsibility for the assigned research group/study.
• Oversee scheduling, performing, and supervising required study tests.
• Orient, train, supervise, and coordinate activities of assigned research staff, providing feedback.
• Responsible for operational aspects of clinical research implementation.
• Coordinate a protocol from inception to completion and problem‑solve…