Research Nurse Coordinator - Worcester, United States - University of Massachusetts Medical School
Description
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Research Nurse Coordinator - Open Rank Job Number : Category: NursingLocation : Worcester, MAShift: DayExempt/Non-Exempt: ExemptBusiness Unit:
UMass Chan Medical SchoolDepartment: School - Center for Clinical Research - W826000
Job Type:
Full-Time
Union Code:
Non Union Position -W60- Non Unit ProfessionalNum
Openings :
1Post Date :
April 16, 2024
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.
ESSENTIAL FUNCTIONS:
Research Nurse Coordinator I:
Review and abstract medical record information in a consistent manner, in accordance with study protocol, institutional, and HIPAA requirementsIn collaboration with the investigational pharmacy, ensure proper adherence to randomization schema, study drug dosing and administration per protocolParticipate in quality assurance internal auditsScreen patients according to study criteria, randomize, enroll, and consent in accordance with GCP standardsMaintain patient/subject confidentiality and strictly adhere to all federal, state, and institutional standards for GCPMaintain business confidentiality as it relates to sponsor, protocol and related regulatory documentsPerform nursing assessments of study participants according to protocol and consult with clinician or Principal Investigator as necessaryDocument and record, in writing or electronically, all study events and protocol related proceduresIdentify adverse events according to study standards; triage, report, and document with the Principal Investigator according to IRB and sponsor requirementsSchedule, perform, and/or coordinate all study procedures according to protocol requirements and sponsor conventionsResponsible 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 necessaryReview clinical system billing charges for accuracy and appropriatenessEnsure that all required study event and protocol related data is accurately and efficiently entered into the clinical trial management systemAttend meetings, conferences, seminars, and applicable training as requiredEnsure 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 requirementsPerform other duties as required.
Research Nurse Coordinator II:
Duties noted above plus:
Assist the Principal Investigator in feasibility and budget assessments for research studies, recommend changes and adjustments as necessaryResponsible for the protocol specific training of the study team and clinical staffAssist in the development of research protocols, case report forms, and case report form completion guidelinesMaintain and coordinate all aspects of complex study conduct, including data and source documentation, adverse event reporting, and communications with the IRBIn collaboration with the Principal Investigator, assist in collation, writing, and editing of research resultsProvide feasibility assessment of research study protocol requirements and design a recruitment plan for assigned clinical studiesTake primary responsibility for creation and maintenance of all regulatory documents, including initial IRB submission, continuing review submissions, and FDA and sponsor required regulatory documentsOrganize and maintain appropriate regulatory documents in accordance with sponsor and institutional standards throughout the life of the studyResponsible for all regulatory paperwork and to report findings to the Principal Investigator, sponsor, and IRB when necessary
Sr Research Nurse:
Duties noted above plus:
Review new research protocols to assess feasibilityAdministratively responsible for recruiting, screening assigning, monitoring, maintaining, and terminating study subjectsCommunicate with outside vendors to obtain the services required to meet the need of the research protocolAssume administrative responsibility for the assigned research group/studyAdministratively responsible for scheduling, performing, and/or supervising required study testsOrient, train, supervise, and coordinate the activities of and provide feedback to assigned Research staffResponsible for the operational aspects of the clinical research implementationCoordinate a protocol from its inception to completion and problem solve difficulties during it life cycle
REQUIRED QUALIFICATIONS:
RN with current registration to practice nursing in Massachusetts3-5 years of relevant nursing experienceProficiency in electronic medical records and relevant computer softwareStrong oral and written communication skills, attention to detail is essentialAbility to work in a team environment to facilitate the integrity of the study and its timely completionAbility to travel to off-site locations
PREFERRED QUALIFICATIONS:
Experience with OnCore and EpicPhlebotomy and EKG skillsBLS CertificationResearch Nurse Coordinator IIRequirements noted for RNC I plus:5-7 years of relevant nursing experience, 2 years of which must be research nurse coordinator experienceSr Research NurseRequirements for RNC I plus:7-9 years of relevant nursing experience, 3 years of which must be research nurse coordinator experienceUMass Chan Medical School was among 23 companies that stood out as 2023 DEI champions, according toThe Boston Globe.