GENERAL SUMMARY OF POSITION: 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.
MAJOR RESPONSIBILITIES: 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 staff Assist 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 studiesParticipate in Quality Assurance internal auditsTake primary responsibility for creation and maintenance of all regulatory documents, including initial IRB submission, continuing review submissions, and FDA and sponsor required regulatory documentsScreen patients according to study criteria, randomize, enroll, and consent in accordance with GCP standardsPerform nursing assessments of study participants according to protocol and consult with clinician or Principal Investigator as necessarySchedule, perform, and/or coordinate all study procedures according to protocol requirements and sponsor conventionsReview and abstract medical record information in a consistent manner, in accordance with study protocol, institutional, and HIPAA requirementsOrganize and maintain appropriate regulatory documents in accordance with sponsor and institutional standards throughout the life of the studyIn collaboration with the investigational pharmacy, ensure proper adherence to randomization schema, study drug dosing and administration per protocolResponsible for all regulatory paperwork and to 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 systemDocument and record, in writing or electronically, all study events and protocol related proceduresMaintain 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 documentsAttend 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 institutional health, safety, and infections control regulations and requirements.Perform other duties as required.
REQUIRED QUALIFICATIONS: RN with current registration to practice nursing in Massachusetts5-7 years of relevant nursing experience, 2 years of which must be research nurse coordinator 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 completionMaintain annual clinical partner nurse compliance standards Ability to travel to off-site locations.
PREFERRED QUALIFICATIONS:Bachelors degree in Nursing Experience with OnCore and Epic Phlebotomy and EKG skills Must be certified in BLS