Research Regulatory Assistant - NYU Langone

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, diversity, 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 diversity, inclusion, and individual skills, ideas, and knowledge. For more information, go tomed.nyu.edu, and interact with us onLinkedIn,Glassdoor,Indeed,Facebook,TwitterandInstagram.

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 Research Regulatory Assistant will be responsible for programmatic maintenance support of clinical trials. Reporting to the Program Manager of the Center for Cognitive Neurology Clinical Trials Program, 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:

• Oversee and maintain clinical trial regulatory documents with minimal supervision, including; filing study documents, obtaining signatures, processing personnel changes, revising regulatory documents and maintaining study binders/electronic folders.
• Assist with sponsor and/or CRO's during monitoring visits, site initiation visits, and study close outs.
• Assist with study start up activities, including but not limited to; CTSI, CRSU, Institutional Review Board, Radiation Committee, Safety Committees, Investigational Pharmacy, etc.
• Assist with study protocol amendments and submit applicable documentation to the IRB, sponsor, or other regulatory agencies.
• Obtain continuing approvals from various committees and organizations (i.e. CTSI, CRSU, IRB, Radiation Committee, Safety Committees, Investigational Pharmacy, etc.).
• Maintaining knowledge of Good Clinical Practice (GCP), clinical research activities and guidelines related to consent, ethical conduct and protection of human subjects.
• Assist with IND Safety Report reviews, submissions and reporting.
• Follows up and coordinates resolution of all issues and resolves processing problems, escalating to the Program Manager or PI, as applicable.
• Assist with reporting on study related deliverables, progress reporting, etc.
• Participates in special projects and performs other duties as required.

Minimum Qualifications:
To qualify you must have a Bachelors degree or equivalent combination of education and experience.

Preferred Qualifications:
1-2 years of comparable experience in research and clinical trial related position, IRB experience 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.

NYU Grossman School of Medicine is an equal opportunity and affirmative action employer committed to diversity and inclusion in all aspects of recruiting and employment. All qualified individuals are encouraged to apply and will receive consideration without regard to race, color, gender, gender identity or expression, sex, sexual orientation, transgender status, gender dysphoria, national origin, age, religion, disability, military and veteran status, marital or parental status, citizenship status, genetic information or any other factor which cannot lawfully be used as a basis for an employment decision. We require applications to be completed online.
If you wish to view NYU Grossman School of Medicine's EEO policies, please click here. Please click here to view the Federal "EEO is the law" poster or visit https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm for more information.

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 $48,274.10 - $50,000.00 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.

To view the Pay Transparency Notice, please click here