Research Nurse Coord I

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 inventions. The Research Nurse Coordinator I is a primary resource for study protocol conduct acting as a liaison between the Principal Investigator, institutional review board (IRB), and sponsor 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
  • Organize and maintain appropriate regulatory documents in accordance with sponsor and institutional standards throughout the life of the study
  • Screen patients according to study criteria, randomize, enroll, and consent in accordance with GCP standards
  • Schedule, perform, and/or coordinate all study procedures according to protocol requirements and sponsor conventions
  • Identify adverse events according to study standards; triage, report, and document with the Principal Investigator according to IRB and sponsor requirements
  • In collaboration with the investigational pharmacy, ensure proper adherence to randomization schema, study drug dosing and administration per protocol
  • 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
  • Review and abstract medical record information in a consistent manner, in accordance with study protocol, institutional, and HIPAA requirements
  • 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
  • Attend meetings, conferences, and seminars as required
  • Adhere to all institutional health, safety, and infections control regulations and requirements
  • Adhere to the policies and procedures of any clinical site where study is being performed
  • Perform additional duties as trained and required by study protocols
  • Perform other duties as required.


REQUIRED QUALIFICATIONS:

  • RN with current registration to practice nursing in Massachusetts
  • 3 years of relevant nursing experience
  • Phlebotomy and EKG skills preferred
  • Demonstrated Microsoft office skills
  • 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
  • Ability to travel to off-site locations
SUPERVISION RECEIVED:

Under the direction of the Principal Investigator or designee

SUPERVISION EXERCISED:

May functionally supervise Research Coordinators

ENVIRONMENTAL WORKING CONDITIONS:

Usual office and/or lab environment, may be exposed to bodily fluids

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