Program Manager, Quality Improvement and Education

The University of Southern California is one of the world’s leading private research universities. An anchor institution in Los Angeles, a global center for arts, technology, and international business, USC’s diverse curricular offerings provide extensive opportunities for interdisciplinary study, and collaboration with leading researchers in highly advanced learning environments. With a strong tradition of integrating liberal and professional education, USC fosters a vibrant culture of public service and encourages students to cross academic as well as geographic boundaries in their pursuit of knowledge. For more information, visit www.usc.edu

The Office of Research and Innovation implements the University of Southern California’s (USC) strategic plan by building interdisciplinary research collaborations that address societal needs and by increasing the impact and prominence of our research. The office invests in research initiatives, promotes our research among sponsors, and provides services that ensure that USC achieves the highest ethical standards in its research. The Human Research Protection Program attends specifically to human research at USC and provides direct oversight to the Institutional Review Board (IRB).

The Program Manager, Quality Improvement and Education is a full-time, professional staff member who plays an integral role on the HRPP team. This includes but is not limited to the following:

Job Accountabilities:

· Serves as a regulatory Subject Matter Expert (SME) for faculty, staff, students and ancillary committees on IRB regulations, policies, and practices.

· Conduct detailed analyses of HRPP and IRB work to implement a continuous improvement program. Draft concise summaries of findings to document deficiencies and identify measures for tracking and achieving improvement. Collaborate with process owners in the design, assessment, and improvement of work processes.

· Conduct monitoring to ensure compliance with IRB recommendations and applicable regulations. Investigate and respond to complaints, criticism, or questions regarding regulatory compliance of human participant research. Create self-assessment forms for studies selected by the IRB for annual routine monitoring. Analyze responses to self-assessments and make recommendations for remediation of findings. Respond to requests for for-cause monitoring as directed. Monitor and ensure coordination with reviewing IRBs for oversight of ceded research.

· Provide regulatory, ethical, and administrative guidance to research constituents to ensure they understand and execute their responsibilities. Collaborate with others in the HRPP to coordinate, develop, and deliver training on a broad range of human research protection topics to researchers, research staff, HRPP/IRB staff, IRB Chairs, and IRB committee members.

Minimum Qualifications

Education

· Bachelor’s Degree (Combined experience/education as substitute for minimum education)

Experience

· 5 years

Field of Expertise

· Certified Institutional Review Board Professional eligible required. Relevant experience in IRB. Expertise and education required to be a member of the IRB board and conduct expedited review.

· Previous experience in quality assurance, quality improvement, auditing, and/or investigations.

Preferred Qualifications

Education

· Master’s Degree/Doctoral Degree

Experience

· 8 years

Field of Expertise

· Certified IRB Professional (CIP) certification is preferred

· Previous experience in clinical research and/or previous experience in reviewing human research applications

· Directly related professional experience in quality assurance, quality improvement, auditing, and investigations.

· Attention to detail

· Excellent interpersonal, verbal, written and analytical skills

· Knowledge of medical terminology

· Knowledge of federal, state, local regulations and laws, and routine policies and ethical practices for human subjects research.

In addition, the successful candidate must also demonstrate, through ideas, words and actions, a strong commitment to USC’s Unifying Values.

The annual base salary for this position is $104,394.49. When determining an offer, the University of Southern California considers factors such as the scope and responsibilities of the role, the candidate’s experience, education, training, key skills, internal peer alignment, applicable laws, contractual requirements, grant funding, and market conditions.

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Minimum Education: Bachelor's degree, Combined experience/education as substitute for minimum education Minimum Experience: 3 years Minimum Field of Expertise: Directly related professional experience in area of program specialization.