Research Nurse Coordinator - Open Rank

University of Massachusetts Medical School•Worcester, MA

About The Position

POSITION SUMMARY: 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.

Requirements

RN with current registration to practice nursing in Massachusetts
3-5 years of relevant nursing 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
Ability to travel to off-site locations
5-7 years of relevant nursing experience, 2 years of which must be research nurse coordinator experience
7-9 years of relevant nursing experience, 3 years of which must be research nurse coordinator experience

Nice To Haves

Bachelor’s degree in Nursing
Experience with OnCore and Epic
Phlebotomy and EKG skills
BLS Certification

Responsibilities

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.
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
Review new research protocols to assess feasibility
Administratively responsible for recruiting, screening assigning, monitoring, maintaining, and terminating study subjects
Communicate with outside vendors to obtain the services required to meet the need of the research protocol
Assume administrative responsibility for the assigned research group/study
Administratively responsible for scheduling, performing, and/or supervising required study tests
Orient, train, supervise, and coordinate the activities of and provide feedback to assigned Research staff
Responsible for the operational aspects of the clinical research implementation
Coordinate a protocol from its inception to completion and problem solve difficulties during it life cycle