Senior IRB Operations & Protections Manager

NYU Langone Hospitals; New York (NY); On-site; USD 101,000 - 125,000; Full time

Benefits offered by this job

Comprehensive benefits

Wellness program

Employee resources groups

Job summary

NYU Langone Health in New York seeks a Senior Scientific Manager - Human Research Protections to lead day-to-day operations of the post-approval team, ensure quality reviews, and maintain compliance with federal and NYULH policies.

You will oversee pre-review activities, verify documents, coordinate with investigators, attend board meetings, and provide guidance to researchers and IRB staff while promoting education and training across the research community.

Qualifications

• MA, MPH, MS or BSN required with strong knowledge of human subject regulations.
• 3+ years experience in clinical research or IRB regulatory work.
• Excellent written and verbal communication; strong organizational skills.

Responsibilities

• Oversee day-to-day operations of post-approval team including ongoing workload management.
• Conduct quality assurance reviews using weekly reports and determine workload status.
• Ensure evaluations and deficiencies are communicated to PI; resolve issues with pre-review staff.
• Work with pre-review staff to clarify identified deficiencies to investigators.
• Perform final review of continuations, amendments and study closures for expedited review.
• Verify completeness and accuracy of applications using the review checklist.
• Analyze submission documents for compliance with NYULH policies and applicable laws.
• Follow up with PIs on outstanding issues from pre-review for RNIs and amendments.
• Provide education and training to researchers and IRB staff; attend professional conferences.

Skills

IRB regulatory knowledge

Project management

Communication skills

Independent judgment

Education

MA, MPH, MS or BSN

Tools

IRB Software

MS Word

PowerPoint

Job description

NYU Langone Health in New York seeks a Senior Scientific Manager - Human Research Protections to lead day-to-day operations of the post-approval team, ensure quality reviews, and maintain compliance with federal and NYULH policies.

You will oversee pre-review activities, verify documents, coordinate with investigators, attend board meetings, and provide guidance to researchers and IRB staff while promoting education and training across the research community.