Research Nurse Coord I

Overview:

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.

Responsibilities:

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.

Qualifications:

REQUIRED QUALIFICATIONS:

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.

Additional Information:

PREFERRED QUALIFICATIONS:

Bachelor's degree in Nursing

Experience with OnCore and Epic

Phlebotomy and EKG skills

BLS Certification