Job Description

Position Summary:

We have an exciting opportunity to join our team as a Senior Scientific Manager - Human Research Protections.

Reporting to the Director of the IRB, the Senior Scientific Manager (SSM) is responsible for overseeing the efficient operations of all post approval submissions (projects having already received initial approval by the IRB) and all processes related to final determination for post approval submissions, Reportable New Information (RNI) submissions, and acts as the primary liaison with the relevant investigators. The SSM is responsible for oversight of the post-approval IRB teams. The SSM will also provide vacation and sick leave coverage for other Sr. Scientific Managers and Scientific Managers.

Job Responsibilities:

• Oversee day-to-day operations of post-approval team including
• Conduct quality assurance reviews using weekly database reports and/or searches to determine status of workload.
• Ensure that evaluations and deficiencies of submissions are communicated to PI by the pre-review staff and when necessary work to resolve any issues.
• Work with associated pre-review staff when necessary to formulate clarification request regarding identified deficiencies to Investigator
• Perform final review of continuations, amendments and study closures that qualify for expedited review in accordance with NYU LH policy and procedures and federal regulations including
• Verify the completeness and accuracy of the application and the required documentation using the appropriate review checklist.
• Thoroughly analyze the submission documents (protocol, consent and other relevant documents) to ascertain compliance with NYULH policies & procedures, applicable federal, state and local law, and Good Clinical Practices.
• When required, conducts regular follow-up with PIs on all outstanding issues resulting from pre-review for all continuations, amendments and responses.
• Perform pre-review of RNIs in accordance with NYULH policy and procedures and federal regulations including:
• Verify the completeness and accuracy of the application and the required documentation using the appropriate review checklist.
• Thoroughly analyze the submission documents (protocol, consent and other relevant documents) to ascertain compliance with NYULH policies & procedures, applicable federal, state and local law, and Good Clinical Practices.
• Conduct regular follow-up with PIs on all outstanding issues resulting from pre-review for all RNIs..
• Ensure all decisions are relayed to PI through official IRB correspondence in electronic mail format.
• Make final determination on any submissions (continuation or amendment) that qualify for full board review
• Ensure that all submissions are data entered in electronic database system on a daily basis
• Attend board meetings as a voting member when necessary.
• When necessary, oversee day-to-day operations of New Study Team and coverage of Scientific Managers for review of Full Board and Expedited new submissions
• Provide vacation and sick coverage for other Sr. Scientific Research Manager and Scientific Managers when necessary.
• Provide high-level guidance and assistance to researchers and IRB staff; through education and training.
• Provide organized and planned educational sessions for research community.
• Attend annual professional conferences
• Maintain education and training to ensure current and up to date knowledge for all job related aspects.
• Work with Director on special projects, policy formulation and protocol specific issues as necessary
• Provide support and assistance for any additional work as required by Director.

Minimum Qualifications:

To qualify you must have a MA, MPH, MS, RN.Solid command of human subject regulations and policies.

Must exercise a high degree of independent judgment and discretion relating to research protocol issues.

Superior organizational, analytical, time management, multi-tasking and interpersonal communication skills required.Excellent verbal and technical writing skills, proficient use of computer and relevant software and database applications (IRB Software, MS Word, PowerPoint, etc.)

Three + years experience in clinical research and/or IRB regulatory work.

Preferred Qualifications:

Certified IRB Professional (CIP) certification preferred OR to be obtained within 1 year of employment.

A candidate with strong clinical background

Qualified candidates must be able to effectively communicate with all levels of the organization.

NYU Grossman School of Medicine provides its staff with far more than just a place to work. Rather, we are an institution you can be proud of, an institution where youll feel good about devoting your time and your talents. At NYU Langone Health, we are committed to supporting our workforce and their loved ones with a comprehensive benefits and wellness package. Our offerings provide a robust support system for any stage of life, whether its developing your career, starting a family, or saving for retirement. The support employees receive goes beyond a standard benefit offering, where employees have access to financial security benefits, a generous time-off program and employee resources groups for peer support. Additionally, all employees have access to our holistic employee wellness program, which focuses on seven key areas of well-being: physical, mental, nutritional, sleep, social, financial, and preventive care. The benefits and wellness package is designed to allow you to focus on what truly matters. Join us and experience the extensive resources and services designed to enhance your overall quality of life for you and your family.

NYU Langone Health provides a salary range to comply with the New York state Law on Salary Transparency in Job Advertisements. The salary range for the role is $101,493.51 - $125,280.27 Annually. Actual salaries depend on a variety of factors, including experience, specialty, education, and hospital need. The salary range or contractual rate listed does not include bonuses/incentive, differential pay or other forms of compensation or benefits.

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