Senior IRB Operations & Compliance Manager

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

Job summary

NYU Langone Health is seeking a Senior Scientific Manager - Human Research Protections in New York, NY. You will oversee daily post-approval operations, perform quality assurance, and ensure timely, accurate communications with investigators under NYULH policy and federal regulations.

The role requires a strong background in human subjects protections, excellent verbal and written communication, and the ability to manage complex submissions and board processes.

Qualifications

• MA, MPH, MS, or RN with solid command of human subject regulations and policies.
• Independent judgment and discretion in handling research protocol issues.
• Strong organizational, analytical, time management, multitasking and interpersonal communication skills.
• Excellent verbal and technical writing skills; proficient with typical software and databases.
• Three+ years of clinical research and/or IRB regulatory experience.

Responsibilities

• Oversee day-to-day operations of post-approval team.
• Conduct QA reviews using weekly reports to determine workload status.
• Ensure evaluation and deficiencies are communicated to PIs by pre-review staff.
• Coordinate with pre-review staff to clarify deficiencies with 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 laws.
• Follow up with PIs on outstanding issues from pre-review.
• Provide pre-review of RNIs in line with policy and regulations.
• Relay all decisions to PIs through official IRB correspondence.
• Attend board meetings as a voting member when needed.
• Offer support to New Study Team and cover when necessary.

Skills

Independent judgment

Organizational skills

Analytical skills

Communication

Technical writing

Education

MA/MPH/MS/Nurse (RN)

Tools

IRB Software

MS Word

PowerPoint

Job description

NYU Langone Health is seeking a Senior Scientific Manager - Human Research Protections in New York, NY. You will oversee daily post-approval operations, perform quality assurance, and ensure timely, accurate communications with investigators under NYULH policy and federal regulations.

The role requires a strong background in human subjects protections, excellent verbal and written communication, and the ability to manage complex submissions and board processes.