About Us:
This position presents an opportunity for an individual with a commitment to the ethical conduct of research and outstanding credentials to assist with the day-to-day operations of the human research protection program at Montefiore Einstein.
POSITION RESPONSIBILITIES:
- Provides leadership, guidance and management on all aspects of day-to-day operations, maintaining a culture of excellence, superior end-to-end service and rapid turnaround times.
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Oversees OHRA review committees including IRB and ancillary commmittees within the department.
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Oversees compliance with ClinicalTrials.gov, including an understanding of intersecting regulations governing human subjects research.
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Serves a key leader within the institution, proactively collaborating with Montefiore Einstein leadership on system-wide process improvement and compliance functions.
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Oversees IRB software system, including overarching process, functionality, and troubleshooting of issues.
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Ensures compliance with internal/external policies & requirements. Maintains current knowledge/expertise in federal, state, local & institutional policies, procedures & guidelines.
- Partners with Executive Director and departmental leadership to pro-actively identify areas for quality improvement, including QI plans, assessment, and implementing training and improvement plans within the department.
- Assists with OHRA policy and procedure development to inform best strategic approaches & enhance effectiveness.
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Serves as a voting member of the IRB.
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Serves as the direct supervisor of a team of IRB analysts and managers, including tracking performance and conducting annual performance evaluations. In consultation with the Executive Director, addresses staff conflict and individual performance issues.
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Assists with evaluation of board composition and IRB member performance reviews on an ongoing basis.
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Assists in identifying and tracking key IRB performance metrics and staff performance management. Ensures high quality reporting in alignment with institutional needs.
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In consultation with Executive Director, evaluates space and staffing needs.
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Reviews IRB meeting minutes to ensure they are accurate and meet regulatory requirements.
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Assists with onboarding/training new IRB members and providing ongoing education to current IRB members on various human research protections.
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Assists with conducting training and education outreach for the research community.
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In consultation with Executive Director, addresses issues of serious/continuing non-compliance and unanticipated problems involving risk to participants or others.
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Serves as deputy to Executive Director, including acting in this capacity (with defined responsibilities) in his/her absence, attends meetings on behalf of the director, or serves as delegate on institutional committees, as needed.
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Performs other related duties as assigned
QUALIFICATIONS:
- Bachelor’s degree required.
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Graduate degree in a relevant field (ethics, biology, philosophy, public heath, etc.) a plus.
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5-7+ years IRB administrative experience.
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Equivalent combination of education and experience will be considered.
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CIP certification required within 6 months of hire.
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Experience within an academic medical center strongly preferred.
Minimum Salary Range: USD $120,000.00/Yr. Maximum Salary Range: USD $135,000.00/Yr.
