Research Nurse Coordinator II
University of Massachusetts Medical School - Worcester, MA

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

Responsibilities:

MAJOR RESPONSIBILITIES:
  • Maintain and coordinate all aspects of complex study conduct, including data and source documentation, adverse event reporting, and communications with the IRB
  • Take primary responsibility for creation and maintenance of all regulatory documents, including initial IRB submission, continuing review submissions, and FDA and sponsor required regulatory documents
  • Provide feasibility assessment of research study protocol requirements and design a recruitment plan for assigned clinical studies
  • Assess study budget and recommend changes and adjustments as necessary
  • In collaboration with the Principal Investigator, assist in collation, writing, and editing of research results
  • 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
  • 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 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.

Qualifications:

REQUIRED QUALIFICATIONS:
  • RN with current registration to practice nursing in Massachusetts
  • 5 years of relevant nursing experience, 2 years of which must be research nurse coordination experience
  • GCP Training
  • Phlebotomy and EKG skills
  • Certification as a CCRC or CCRP 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 coordinate a protocol from its inception to completion and problem solve difficulties during it life cycle
  • Ability to travel to off-site locations
SUPERVISION RECEIVED :

Under the general direction of the Principal Investigator or designee

SUPERVISION EXERCISED:

May functionally supervise Research Nurse and Research Coordinators

ENVIRONMENTAL WORKING CONDITIONS:

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

Additional Information:

Hematology / Oncology research experience preferred.

University of Massachusetts Medical School - 15 months ago - save job - block
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