Research Nurse Coord I -Per Diem

University of Massachusetts Medical School•Worcester, MA

21h•Hybrid

About The Position

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

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
Maintain annual clinical partner nurse compliance standards
Ability to travel to off-site locations.

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.