Senior Institutional Review Board Analyst

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 (HRPP) attends specifically to human research at USC and provides direct oversight to the Institutional Review Board (IRB).

The HRPP is seeking candidates to fill two Senior IRB Analyst openings in the HRPP. One will be primarily focused on Reliance or Single IRB applications, the other on Social Behavioral. Reporting to a Lead IRB Analyst, the Senior IRB Analyst position is a full-time, professional staff member who plays an integral role in the day-to-day functions for the Office. The Reliance/Single IRB position 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 and single 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 reliance and single IRB 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 reliance or single IRB 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 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.

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 range for this position is $82,670.83–$83,000.00 . 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 education/experience as substitute for minimum education Minimum Experience: 5 years, Combined education/experience as substitute for minimum experience Minimum Field of Expertise: Certified Institutional Review Board Professional required. Relevant experience in IRB. Expertise and education required to be a member of the IRB board and conduct expedited review.