The Senior IRB Analyst is responsible for facilitating the ethical conduct of research with human subjects by screening and reviewing human subjects research submissions in the area of social behavioral research for completeness and adherence to IRB policy, institutional requirements, and state/federal regulations. Under administrative direction, the Senior IRB Analyst will serve as a member of the Institutional Review Board (IRB); facilitate the review and approval process by interpreting and applying relevant federal and state laws, regulations, and institutional policies and guidelines; conduct research and prepare guidance and reports on regulatory topics, precedent, and changes; instruct IRB members and researchers on the policies, regulations, and ethical principles essential to the review process; and provide training and advice to faculty, staff, and student researchers on the regulations and preparation of applications and materials.
Interpret and apply federal and state laws, regulations, institutional policies and guidelines to protect human subjects and to ensure institutional compliance.
Draft agendas, meeting minutes, and other documentation of IRB Committee findings.
Author and disseminate correspondence that conveys both screening results and the IRBs deliberations and contingencies for approval of research activities involving human subjects.
Assist in the development of standards for submissions to the IRB to ensure the quality of submissions to decrease the turnaround times for IRB approval.
Identify areas for improvement in current IRB processes, define strategies to optimize IRB operations and assist in the implementation of these strategies for process improvement.
Conduct research to prepare guidance and reports for the IRBs on scientific, ethical, and regulatory topics.
Provide regulatory and ethical advice to faculty, staff, and students.
Prepare reports on office metrics.
Other program-related duties and projects as required.
Demonstrated ability to work independently, exercise sound judgment and multi-task. Ability to communicate in a professional, positive and persuasive manner (both orally and in writing). Strong administrative and project management skills.
EDUCATION, EXPERIENCE, AND CERTIFICATIONS:
Bachelor’s Degree Required. Certified IRB Professional (CIP) Certification preferred. Three or more years of relevant work experience as an IRB administrator or equivalent preferred. At least four years of experience working in a human subjects’ research-related area required. Knowledge of ethical principles, regulations, and policies related to human subjects research.
TECHNICAL KNOWLEDGE OR SKILLS:
Experience with online IRB protocol management software preferred
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