Research Nurse Coord Ii

Job Description



Under the direction of the Principal Investigator or designee, the Research Nurse Coordinator II is responsible to carry out all delegated tasks related to complex protocols testing investigational drugs, devices, or research interventions. The Research Nurse Coordinator II 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.



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
Participate in Quality Assurance internal audits
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
Screen patients according to study criteria, randomize, enroll, and consent in accordance with GCP standards
Perform nursing assessments of study participants according to protocol and consult with clinician or Principal Investigator as necessary
Schedule, perform, and/or coordinate all study procedures according to protocol requirements and sponsor conventions
Review and abstract medical record information in a consistent manner, in accordance with study protocol, institutional, and HIPAA requirements
Organize and maintain appropriate regulatory documents in accordance with sponsor and institutional standards throughout the life of the study
In collaboration with the investigational pharmacy, ensure proper adherence to randomization schema, study drug dosing and administration per protocol
Responsible for all regulatory paperwork and to 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
Document and record, in writing or electronically, all study events and protocol related procedures
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
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 institutional health, safety, and infections control regulations and requirements.
Perform other duties as required.



RN with current registration to practice nursing in Massachusetts
5-7 years of relevant nursing experience, 2 years of which must be research nurse coordinator experience
Proficiency in electronic medical records and relevant computer software
Strong oral and written communication skills, attention to detail is essential
Ability to work in a team environment to facilitate the integrity of the study and its timely completion
Maintain annual clinical partner nurse compliance standards
Ability to travel to off-site locations.

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