Senior Institutional Review Board Analyst
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 an IRB Lead/Manager, 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. 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 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, including Ceded/single IRB applications, and to approve changes in approved research that are eligible for expedited review. Acts as a liaison between external IRBs and researchers, serving as a point of contact. For studies that qualify for review by an external IRB, conducts independent, in-depth reviews focusing on institutional and regulatory compliance, such as assuring study personnel have completed required training, and assuring the protocol and informed consent are consistent with institutional requirements, federal, state or local laws and policies. Assures that all ancillary committee reviews have been conducted as required by institutional policies. Reviews, and facilitates the execution of IRB reliance agreements. Completes local context forms or other reliance documents required by external IRBs. 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/or correspondence that effectively describe concerns raised by the reviewers and/or member(s), changes required by the reviewer(s) and/or member(s) to make the study approvable, and the rationale for the reviewer(s), member(s) and/or decisions by the Full Board 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. 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.
Salary Range:
$80K -- $100K
Minimum Qualification
TeachingEstimated Salary: $20 to $28 per hour based on qualifications.
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 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, including Ceded/single IRB applications, and to approve changes in approved research that are eligible for expedited review. Acts as a liaison between external IRBs and researchers, serving as a point of contact. For studies that qualify for review by an external IRB, conducts independent, in-depth reviews focusing on institutional and regulatory compliance, such as assuring study personnel have completed required training, and assuring the protocol and informed consent are consistent with institutional requirements, federal, state or local laws and policies. Assures that all ancillary committee reviews have been conducted as required by institutional policies. Reviews, and facilitates the execution of IRB reliance agreements. Completes local context forms or other reliance documents required by external IRBs. 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/or correspondence that effectively describe concerns raised by the reviewers and/or member(s), changes required by the reviewer(s) and/or member(s) to make the study approvable, and the rationale for the reviewer(s), member(s) and/or decisions by the Full Board 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. 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.
Salary Range:
$80K -- $100K
Minimum Qualification
TeachingEstimated Salary: $20 to $28 per hour based on qualifications.
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