Research Regulatory Assistant

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.

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Position Summary:

We have an exciting opportunity to join our team as a Research Regulatory Assistant.An integral member of the research team and in compliance with all regulatory institutional and departmental requirements, the incumbent will be responsible for programmatic maintenance support of clinical trials. Reporting to the Senior Manager of Regulatory Affairs Unit, your specific responsibilities will include assistance with clinical trial regulatory responsibilities. You will serve as a liaison between the IRB and internal departments/staff.

Job Responsibilities:

• Assist Senior Regulatory Specialists and Regulatory Specialists with their day-to-day activities, including but not limited to: obtaining signatures on regulatory documents, filing study documents, processing personnel changes, revising regulatory documents and maintaining study binders/electronic folders.
• Assist Regulatory Specialists with IND Safety Report reviews, submissions, and reporting.
• Assist Regulatory Specialists with sponsor and/ or CROs during monitoring visits.
• Assist Research Nurses with administrative tasks as needed.
• Assist research teams in preparing for DMG meetings.
• Assist Regulatory Specialists in obtaining continuing approvals from various committees and organizations (In-house: Scientific Committee, Institutional Review Board, Biosafety Committee, Radiation Committee.
• Maintaining knowledge of Good Clinical Practice (GCP), clinical research activities and guidelines related to consent, ethical conduct and protection of human subjects.

Minimum Qualifications:

To qualify you must have a Bachelor's degree or equivalent combination of education and experience.

Preferred Qualifications:

1 year of comparable experience in research/hospital planning and operations. Knowledge of oncology clinical trials and oncology terminology preferred. A working knowledge of government codes/regulations preferred.

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.

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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 $48,274.09 - $53,000.00 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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