Senior Research Nurse

Senior Research Nurse

Minimum Salary

US-MA-Worcester

Job Location

6 days ago(3/10/2023 11:00 AM)

Requisition Number

2022-40806

# of Openings

1

Posted Date

Day

Shift

Exempt

Overview

GENERAL SUMMARY OF POSITION: Under the direction of the Principal Investigator or designee, the Sr Research Nurse is responsible to carry out all delegated tasks related to complex protocols testing investigational drugs, devices, or research interventions. The Sr Research Nurse is a primary resource for study protocol conduct acting as a liaison between the University of Massachusetts Chan Medical School, 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.

Responsibilities

MAJOR RESPONSIBILITIES: 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 cycleIn collaboration with the Principal Investigator, assist in collation, writing, and editing of research resultsAssist 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 IRBReview 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 documentsSchedule, perform, and/or coordinate required 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.

Qualifications

REQUIRED QUALIFICATIONS: RN with current registration to practice nursing in Massachusetts7-9 years of relevant nursing experience, 3 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.

Additional Information

PREFERRED QUALIFICATIONS: Bachelor's degree in NursingSoCRA or ACRP certificationExperience with OnCore and EpicAbility to insert intravenous cathetersPhlebotomy and EKG skillsBLS Certification *LI-AT1