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University of Rochester Research Quality Improvement Specialist - 228256 in Rochester, New York

Research Quality Improvement Specialist Job ID 228256

Location Central Administration Full/Part Time Full-Time Favorite Job Regular/Temporary Regular Opening

Full Time 40 hours Grade 054 Office for Human Subject Prot

Schedule

8 AM-5 PM

Responsibilities

GENERAL PURPOSE:

Conduct internal audits of Human Subject Research Studies to measure compliance with IRB requirements, the approved protocol, applicable federal regulations, University policies, and best practice (Good Clinical Practice) standards. Conduct internal consultations regarding newly-approved studies with Investigators and study team members to plan for compliance with IRB requirements, the approved protocol, applicable federal regulations, University policies, and best practice (Good Clinical Practice) standards. The emphasis of the position and the program is on improving the quality of research compliance and providing education and feedback to research teams to protect human subjects. This position functions in all areas of human subject research including biomedical, behavioral, and social science research.

SPECIFIC RESPONSIBILITIES:

  • Prepare, plan, and execute quality improvement audits (routine, directed, or site-requested) to ensure the protection of human subjects and that research is conducted in accordance with IRB requirements, the approved protocol, applicable federal regulations, University policies, and best practice (Good Clinical Practice) standards. Assist University research sites by participating and assisting in the preparation for regulatory audits/inspections from governmental agencies and research sponsors. These activities include review of affiliated research centers, as necessary. (40%)

  • Prepare, plan, and execute quality improvement consultations (i.e. Study Start Up, Quality Management) to ensure the protection of human subjects and that research is conducted in accordance with IRB requirements, the approved protocol, applicable federal regulations, University policies, and best practice (Good Clinical Practice) standards. (20%)

  • Prepare formal quality improvement audit reports of findings, participate in decisions on audit outcomes, and provide consultation and educational services to study team(s) to improve the research process and to create corrective and preventative action plans. Prepare written summaries of quality improvement consultation discussions providing resources specific to the approved study. (30%)

  • Suggest improvements to the OHSP Standard Operating Procedures for Conducting Quality Improvement Audits and Consultations. Provide input to policy and guidelines for departmental procedures and business systems. Participate in all aspects of communicating UR quality improvement activities and results (i.e. presentations, annual Chair reports, quarterly newsletter). (5%)

  • Maintains current knowledge of Good Clinical Practice (CGP), federal and state regulations, IRB policies & procedures, ethical standards and best practices associated with conducting research with human subjects. (5%)

    REQUIREMENTS:

  • Bachelor’s degree in nursing, allied health, life science, or appropriate technical field with 3-5 years of clinical trials related (drugs/devices) experience or an appropriate combination of education and experience.

  • Required: Excellent verbal, written, and critical thinking skills, with solid interpersonal skills. Ability to set priorities and work both independently and collaboratively. Must have the ability to work with faculty, professional staff, research administrators, and others to improve human subject protection. Deals with highly confidential and complex information and must be able to exercise independent judgment.

  • Highly desirable: Experience monitoring, overseeing research activities, GCP compliance auditing experience.

  • Computer skills: Familiarity with on-line systems (Huron Research Suite modules, REDCap, CTMS, EPIC) and productivity programs such as Microsoft Word, Excel, and Powerpoint.

    NOTE: This document describes typical duties and responsibilities and is not intended to limit management from assigning other work as required.

    How To Apply

All applicants must apply online.

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