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Institutional Review Board Analyst II - Office of Research

USC Institutional Review Board Los Angeles, California

The Office of Research (“Office”) is implementing the University of Southern California’s 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.

Reporting to the IRB Associate Director, the IRB Analyst II position is a full-time, professional staff member who plays an integral role in the day-to-day functions for the Office.  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.
  • Serves as a secondary point of contact for questions, and for decision-making and problem-solving for day-to-day IRB operations including the resolution of technical problems and questions of IRB support staff, IRB members, researchers and investigators. Conducts reviews of biomedical and behavioral research studies in compliance with Federal regulations and Institutional policies and procedures. Under supervision, identifies issues or concerns that must be addressed in order to approve the research under the exempt and expedited procedures and records review findings in tracking software in a timely manner.
  • Assists investigators and research staff on IRB submission requirements.
  • Serves as a member of the Institutional Review Board (IRB). Serves as a designated reviewer with the authority to make determinations with minimal supervision, to approve expedited research, and to approve changes in approved research that are eligible for expedited review.
  • Attends Institutional Review Board (IRB) meetings to provide technical support, guidance on regulatory matters and ethics, and provide critical analysis of proposal content. Provides answers to questions raised by the board members.
  • Conducts reviews of biomedical and behavioral research proposals submitted to the IRB in compliance with Federal regulations and Institutional policies and procedures. Makes an initial determination regarding the necessary level of review. Identifies issues or concerns that must be addressed in order to approve the research.
  • Composes detailed and complex meeting minutes and correspondence that effectively describe concerns raised by Board reviewers, changes required by the Board to make the study approvable, and the rationale for the Board’s decisions and requested changes.
  • Assists in the training of and mentoring of Institutional Review Board Analysts and other staff.
  • Assists in the development of IRB education, training, and guidance materials for the research community.
  • Demonstrates familiarity with department operations and makes recommendations for their improvement.

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.

Preferred Qualifications

Education       

  • Bachelor’s Degree

Experience

  • Certified IRB Professional (CIP) certification is preferred
  • Previous experience in clinical research and/or previous experience in reviewing human subjects applications
  • Attention to detail
  • Excellent interpersonal, verbal, written and analytical skills
  • Knowledge of medical terminology

Field of Expertise       

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

Preferred Field of Expertise:

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


The Institutional Review Board (IRB) Analyst II is responsible for regulatory review of social-behavioral and/or biomedical research proposals of various complexity and risk, submitted to IRB review. The role directly impacts subject health and wellbeing through independently reviewing submissions, verifying that all institutional requirements have been met, and determining whether applicable regulations and policies are appropriately addressed. The position identifies ethical and regulatory issues, analyzing and applying federal and state regulations, University policies and ethical principles governing research protocols submitted to the Institutional Review Board (IRB). Job duties include, but are not limited to: • Reviews each submission to ensure that all applicable regulations and institutional requirements will be met • Edits informed consent documents to simplify language and improve readability for a general audience • Attends IRB meetings and prepares minutes that document the IRB’s determinations and that effectively describe the concerns, rationale, and technical questions of the IRB • Responsible for evaluating modifications, and continuing review of ongoing research. • Coordinate approval of IRB reliance agreements and monitor USC’s responsibilities under these agreements • Review requests for USC investigators to rely on a non-USC IRB and for USC to serve as the IRB for non-USC sites • Participates in continuous quality improvement activities in conjunction with USC’s Office for the Protection of Research Subjects • Assists in the development, distribution, and utilization of IRB education, training, and guidance material.



REQ20086329 Posted Date: 04/07/2020

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