Senior IRB Analyst

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Job Summary:

Assists the Director of Human Research Protections in ensuring compliance with all federal and state statutes and regulations on protection of human subjects. Able to lead IRB staff and conduct staff training. Represents the IRB through attendance on local committees and IRB meetings, support the maintenance of accreditation, and conduct initial investigations of study or programmatic non-compliance. Executes and maintains reliance agreements as needed. Serves as a regulatory Subject Matter Expert (SME) for staff, students and IRB members on IRB regulations, policies, and procedures. Provides education as needed.

Position Responsibilities

Assist with the management of daily IRB operations.

Conduct reviews of biomedical and social behavioral research studies in compliance with Federal regulations and Institutional policies and procedures.

• Make an initial determination regarding the necessary level of review.
• Identify issues or concerns that must be addressed to approve the research.
• Make an initial determination regarding the necessary level of review. Identifies issues or concerns that must be addressed to approve the research under the exempt, expedited, and full board procedures and record review findings in tracking software in a timely manner.
• Serve as reviewer for exempt or expedited reviews.
• Oversight of Reliance Agreements

Work closely with investigators during the review and approval process and advises researchers on regulatory and ethical standards as well as institutional policies and procedures; provides consultation to the research community on submission requirements.

Support the various IRB members by conducting pre-reviews of requests for modification of previously approved research; requests for continuing approval; potential reportable events; conducting pre-reviews of responses to initial review; and preparing/contributing to agendas, minutes, and correspondence.

Assist with the development, revision, and implementation of policies and procedures to ensure compliance with all applicable regulations policies, and guidance.

Participates in IRB quality improvement initiatives including the review of existing IRB policies and procedures, the provision of training for IRB administrative staff, and other internal QA activities.

Position Qualifications Required:

Required Experience:

A minimum of 5 years' experience in clinical research regulatory affairs and human subjects research protection regulations. Detailed knowledge of applicable federal regulations related to IRB and clinical research, experience with compliance aspects of regulatory review and oversight.

Previous experience in reviewing human subjects applications

Attention to detail

Excellent interpersonal, verbal, written and analytical skills Knowledge of medical terminology

Required Education:

Bachelor's degree required (Master's Degree preferred) in relevant area (e.g., nursing, regulatory science)

Training / Certification / Licensure:

Obtain IRB Professional (CIP) certification within the first year of hire.