Edtech.com's Summary

Albert Einstein College of Medicine is hiring an Assistant Director, Operations. The role involves leading and managing the daily functions of the human research protection program, overseeing IRB committees, ensuring regulatory compliance, enhancing process improvements, and supervising IRB staff activities.

Highlights

Lead and manage day-to-day operations of the human research protection program.
Oversee IRB and ancillary review committees and ensure compliance with ClinicalTrials.gov and related regulations.
Manage IRB software systems, troubleshoot issues, and maintain regulatory compliance in documentation.
Collaborate with institutional leadership to implement quality improvement and training initiatives.
Supervise IRB analysts and managers, conduct performance evaluations, and address staff and performance issues.
Assist with policy development, IRB member training, and performance reviews.
Serve as a voting IRB member and act as deputy to the Executive Director when needed.
Requirements include a Bachelor’s degree, 5-7+ years of IRB administrative experience, CIP certification within 6 months of hire, and preferably experience within an academic medical center.
Graduate degree in relevant fields is a plus.
Salary ranges from USD $125,000 to $135,000 per year.

Assistant Director, Operations Full Description

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.
Oversees OHRA review committees including IRB and ancillary commmittees within the department.
Oversees compliance with ClinicalTrials.gov, including an understanding of intersecting regulations governing human subjects research.
Serves 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 & 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.
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

QUALIFICATIONS:

Bachelor’s degree required.
Graduate degree in a relevant field (ethics, biology, philosophy, public heath, 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.

Minimum Salary Range: USD $125,000.00/Yr. Maximum Salary Range: USD $135,000.00/Yr.

Original Job Description

About Us:

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 commmittees within the department.
Oversees compliance with ClinicalTrials.gov, including an understanding of intersecting regulations governing human subjects research.
Serves 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 & 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.
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

QUALIFICATIONS:

Bachelor’s degree required.
Graduate degree in a relevant field (ethics, biology, philosophy, public heath, 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.

Minimum Salary Range: USD $125,000.00/Yr. Maximum Salary Range: USD $135,000.00/Yr.

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