GENERAL SUMMARY OF 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.
MAJOR 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.
– 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.
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