University of Massachusetts Medical School

Quality Improvement Mgr,CCTS

US-MA-Worcester
1 month ago
Requisition Number
2017-29681
# of Openings
1
Shift
Day
Exempt/Non-Exempt Status
Exempt

Overview

GENERAL SUMMARY OF POSITION:

Under the general direction of the Assistant Vice Provost for Clinical Research (OVPR), the Quality Improvement Manager, CCTS is responsible for developing a comprehensive quality improvement initiative to ensure compliance in the day-to-day conduct of clinical studies. The Quality Improvement Initiative, a component of the regulatory domain in the Center for Clinical & Translational Science (CCTS), will encompass internal auditing, and the translation of audit findings to education, training and policy recommendations. 

Responsibilities

MAJOR RESPONSIBILITIES:

  • Develop audit standards to ensure compliance and oversight of clinical research being conducted at UMass, with a strong focus on investigator-initiated research conducted through the center for Clinical & Translational Science 
  • Expand current internal auditing across all human studies to minimum of 10% per annum
  • Respond to institutional leadership or IRB requests to conduct ‘for-cause’ audits, investigating non-compliance and related corrective action requirements
  • Respond to departmental requests for assistance with external audit preparation and training, e.g., from sponsor, funder or regulatory agency
  • Consult with investigators and research professionals as needed for education regarding study initiation requirements, preparation of regulatory documents and other FDA-related requirements
  • Collaborate with Clinical Research Operations Manager to develop responsive education and training programs for best practices in human research
  • Audit IRB files on quarterly and as-needed basis to ensure regulatory compliance with IRB standard operating procedures and to ensure metrics are being met for IRB processes
  • Serve as UMass administrator to maintain OHRP/IRB registration and keep current Federal-wide Assurance (FWA) paperwork
  • Provide support to Assist. Vice Provost for Clinical Research and the Center for Clinical & Translational Science related to on-going changes in regulatory requirements and related institutional response
  • Perform other duties as required

Qualifications

REQUIRED QUALIFICATIONS:

  • Bachelor’s degree in a health care field, or equivalent
  • Master’s degree preferred
  • 5 years experience in an academic human subjects research environment, with an emphasis on monitoring, auditing and/or education and training
  • High level communication skills, both oral and written, necessary to interact with institutional leadership and research community 
  • Ability to perform independently within established policies and procedures
  • Working knowledge of policies, procedures, and requirements of federal and private granting agencies, as well as legal, business and academic requirements
  • Strong organizational skills

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