Senior Scientific Manager - Human Research Protections

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

Senior Scientific Manager - Human Research Protections

Research --> Administration

New York, NY

Full-Time/Regular

NYU Grossman School of Medicine is one of the nation's top-ranked medical schools. For 175 years, NYU Grossman School of Medicine has trained thousands of physicians and scientists who have helped to shape the course of medical history and enrich the lives of countless people. An integral part of NYU Langone Health, the Grossman School of Medicine at its core is committed to improving the human condition through medical education, scientific research, and direct patient care. At NYU Langone Health, equity and inclusion are fundamental values. We strive to be a place where our exceptionally talented faculty, staff, and students of all identities can thrive. We embrace inclusion and individual skills, ideas, and knowledge.

For more information, go to med.nyu.edu, and interact with us on LinkedIn, Glassdoor, Indeed, Facebook, X and Instagram.

Position Summary:

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

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 you'll 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 it's 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 Grossman School of Medicine is an equal opportunity employer and committed to inclusion in all aspects of recruiting and employment. All qualified individuals are encouraged to apply and will receive consideration. We require applications to be completed online.

View Know Your Rights: Workplace discrimination is illegal.

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.

To view the Pay Transparency Notice, please click here