University of Pittsburgh

Assistant Director - Research Operations

University of Pittsburgh$75K — $95K *
Pharmaceuticals & Biotech
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • 5+ years of experience in quality assurance or clinical trial operations
  • Strong knowledge of federal regulations and compliance standards
  • Proven leadership abilities in overseeing audit operations
  • Excellent communication and collaboration skills
  • Ability to develop and maintain standard operating procedures

Responsibilities

  • Direct the daily operations of the Quality Assurance team
  • Oversee audit activities to ensure compliance with audit program goals
  • Participate in cross-office meetings to enhance QA protocols
  • Ensure timely and accurate preparation of audit reports
  • Engage in external audits and maintain audit readiness
  • Support educational training initiatives for member institutions

Benefits

  • Membership in a leading research organization
  • Collaboration with a national network of clinical trial sites
  • Opportunity to shape quality assurance practices
  • Professional development and training opportunities
  • Involvement in impactful cancer research initiatives
Full Job Description
Job Summary

The NRG Oncology Statistics and Data Management Center (NRG SDMC) is a large, national, federally funded multi-center organization that conducts clinical trials research with offices in Pittsburgh, Philadelphia, Buffalo and Chicago. The NRG SDMC office at the University of Pittsburgh is responsible for collection, processing, and management of numerous cancer clinical trials. There are over 1800 clinical sites in our research network which provide over 6,000 participants annually for the NRG Oncology clinical trials.

The Assistant Director - Research Operations directs the local quality assurance program of the SDMC, including the day-to-day audit operations. The Assistant Director supports audit program development and implementation, staff supervision and ensures compliance with Federal regulations, and the development and maintenance of written standard operating procedures. The Assistant Director supports the Center Director and is a member of the local NRG SDMC leadership team.

Job Duties

Directs the daily work of the Quality Assurance Specialists and Quality Assurance Program Manager.

Oversees operations of the Pittsburgh SDMC Quality Assurance Team; collaborating and supporting the audit activities of the broader quality assurance program.

Participates in monthly and semi-annual cross-office quality assurance team meetings.

Ensures all required audit reviews and reports are prepared and submitted timely and accurately in support of the overall goals of the audit program.

Participates in external audits as required.

Supports education and training of member institutions at semi-annual meetings as required.

About University of Pittsburgh

The University of Pittsburgh is a state-related research university located in Pittsburgh, Pennsylvania. It was founded in 1787 and is one of the oldest continuously chartered institutions of higher education in the United States. The university offers a wide range of undergraduate, graduate, and professional degree programs across 17 schools and colleges. The University of Pittsburgh is known for its strong programs in health sciences, engineering, business, and law. It is also home to a number of research centers and institutes, including the Pitt Innovation Institute and the Center for Energy.
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