Research Quality Specialist-Lead

University of PittsburghPittsburgh, PA

About The Position

Coordinates on-site reviews of selected clinical projects to assess compliance with federal regulations, Institutional Review Board (IRB) requirements, and University policies. Monitors and evaluates site visit auditors work and oversees the drug distribution and delivery system. Writes audit reports, facilitates educational programs for the research community, updates information as pertains to federal regulations and applicable policies, and analyzes and conveys audit data to assist in addressing inaccuracies.

Requirements

  • Compliance with federal regulations
  • Knowledge of Institutional Review Board (IRB) requirements
  • Understanding of University policies
  • Experience in monitoring and evaluating site visit auditors
  • Oversight of drug distribution and delivery systems
  • Report writing skills
  • Experience in facilitating educational programs
  • Ability to update information on federal regulations and policies
  • Skills in analyzing and conveying audit data

Responsibilities

  • Coordinates on-site reviews of selected clinical projects to assess compliance with federal regulations, Institutional Review Board (IRB) requirements, and University policies.
  • Monitors and evaluates site visit auditors work.
  • Oversees the drug distribution and delivery system.
  • Writes audit reports.
  • Facilitates educational programs for the research community.
  • Updates information as pertains to federal regulations and applicable policies.
  • Analyzes and conveys audit data to assist in addressing inaccuracies.
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