Research Regulatory Specialist

NYU Grossman School of Medicine; New York (NY); On-site; USD 66,000 - 81,000; Full time

Benefits offered by this job

Financial security benefits

Generous time-off

Employee resource groups

Wellness program

Job summary

NYU Grossman School of Medicine in New York seeks a Research Regulatory Specialist to support initiation and oversight of clinical trials within the Division of Endocrinology. You will act as internal regulatory liaison for sponsor, CRO, IRB, FDA and NYU teams, coordinating submissions and study development.

Responsibilities include coordinating contracts and budgets, preparing regulatory master files, consent forms, and ensuring compliance with GCP and regulatory standards across multiple

Qualifications

• Minimum 2 years of research experience and a Bachelor's degree required.
• Strong knowledge of regulatory compliance requirements and procedures.
• Proficient with MS Office, databases, and data management tools.

Responsibilities

• Initiating contracts & budgets of clinical trials in the internal system for completion by the appropriate legal department at NYU and managing their completion to ensure timely activation.
• Directly communicate with local and national regulatory authorities.
• Complete site qualification questionnaires from potential industry sponsors and analyze division ability to participate.
• Conduct pre-study visits to ensure site meets all requirements to conduct the clinical trial are met.
• Creation of regulatory master files for industry & investigator-initiated endocrinology trials.
• Develop trial specific patient informed consent forms for clinical trials
• Contribute to the development and implementation of local protocols and grants (including consent forms, study calendars, letter of intents (LOIs)), and single patient INDs to ensure they conform to the sponsor & NYU specifications.
• Organizing and preparing site initiation visits with sponsor/CRO & clinical team.
• Collaborate with investigators to prioritize the submission and activation of clinical trials.
• Timely submission of all regulatory documents to ensure that activation timelines are met and track and control all regulatory submissions and disseminate approvals.
• Maintaining updates to regulatory documents and submitting modifications as needed.
• Prepare, submit and obtain initial approval from mandatory scientific review committees (In-house: Protocol Review and Monitoring Committee, Institutional Review Board, Biosafety Committee, Conflicts of Interest Committee and Radiation Committee. External: FDA, NIH, NCI, Cooperative Groups).
• Provide regulatory guidance to study members.
• Maintaining knowledge of Good Clinical Practice (GCP), clinical research activities and guidelines related to consent, ethical conduct and protection of human subjects.

Skills

Regulatory compliance

MS Office

Data management

Communication

Time management

Education

Bachelor's degree

Master's degree in Public Health/Health Administration or relevant science

Tools

MS Office

Database software

Job description

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 Research Regulatory Specialist. The Research Regulatory Specialist will be responsible for programmatic support to initiate clinical trials within the Division of Endocrinology. Reporting to the Research Program Manager, your specific responsibilities will include pre- and post-activation responsibilities. You will serve as the internal regulatory specialist for the research projects to which you are assigned, including providing timely updates on the status of submissions and regulatory guidance on study development. Additionally, you will serve as the liaison between the sponsor, CRO, IRB, FDA and internal departments/ staff.

Job Responsibilities

• Initiating contracts & budgets of clinical trials in the internal system (CDAs & CTAs) for completion by the appropriate legal department at NYU and managing their completion to ensure timely activation.
• Directly communicate with local and national regulatory authorities.
• Complete site qualification questionnaires from potential industry sponsors and analyze division ability to participate.
• Conduct pre-study visits to ensure site meets all requirements to conduct the clinical trial are met.
• Creation of regulatory master files for industry & investigator-initiated endocrinology trials.
• Develop trial specific patient informed consent forms for clinical trials
• Contribute to the development and implementation of local protocols and grants (including consent forms, study calendars, letter of intents (LOIs)), and single patient INDs to ensure they conform to the sponsor & NYU specifications.
• Organizing and preparing site initiation visits with sponsor/CRO & clinical team.
• Collaborate with investigators to prioritize the submission and activation of clinical trials.
• Timely submission of all regulatory documents to ensure that activation timelines are met and track and control all regulatory submissions and disseminate approvals. Maintaining updates to regulatory documents and submitting modifications as needed.
• Prepare, submit and obtain initial approval from mandatory scientific review committees (In-house: Protocol Review and Monitoring Committee, Institutional Review Board, Biosafety Committee, Conflicts of Interest Committee and Radiation Committee. External: FDA, NIH, NCI, Cooperative Groups).
• Provide regulatory guidance to study members.
• 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 Bachelors degree and at least 2 years of research experience. Excellent working knowledge of regulatory compliance requirements and procedures. Knowledge of MS Office suites, database, spreadsheets, graphic and communications applications. Exceptional communication, analytical, presentation and time management skills. Ability to demonstrate impact on project goals through proactive solutions and keeps management aware of project schedules/timelines.

Preferred Qualifications

Masters degree in a relevant discipline such as Public Health, Health Administration or a relevant science is highly desirable.

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.

• financial security benefits
• a generous time-off program
• employee resources groups for peer support
• 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.

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 $66,300.00 - $81,249.00 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.