Assistant Director, Operations

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.

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.
• Oversees OHRA review committees including IRB and ancillary committees within the department.
• Oversees compliance with ClinicalTrials.gov, including an understanding of intersecting regulations governing human subjects research.
• Serves as a key leader within the institution, proactively collaborating with Montefiore Einstein leadership on system-wide process improvement and compliance functions.
• Oversees IRB software system, including overarching process, functionality, and troubleshooting of issues.
• Ensures compliance with internal/external policies and requirements.
• Maintains current knowledge/expertise in federal, state, local, and institutional policies, procedures, and guidelines.
• Partners with Executive Director and departmental leadership to proactively 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 and enhance effectiveness.
• Serves as a voting member of the IRB.
• 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.
• Assists with evaluation of board composition and IRB member performance reviews on an ongoing basis.
• Assists in identifying and tracking key IRB performance metrics and staff performance management.
• Ensures high-quality reporting in alignment with institutional needs.
• In consultation with Executive Director, evaluates space and staffing needs.
• Reviews IRB meeting minutes to ensure they are accurate and meet regulatory requirements.
• Assists with onboarding/training new IRB members and providing ongoing education to current IRB members on various human research protections.
• Assists with conducting training and education outreach for the research community.
• In consultation with Executive Director, addresses issues of serious/continuing non-compliance and unanticipated problems involving risk to participants or others.
• 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.
• Performs other related duties as assigned.

Requirements

• Bachelor’s degree required.
• Graduate degree in a relevant field (ethics, biology, philosophy, public health, etc.) a plus.
• 5-7+ years IRB administrative experience.
• Equivalent combination of education and experience will be considered.
• CIP certification required within 6 months of hire.
• Experience within an academic medical center strongly preferred.

Pay

Minimum Salary Range: USD $125,000.00/Yr.

Maximum Salary Range: USD $135,000.00/Yr.