NYU Langone is one of the nation's premier academic medical centers that includes five hospitals (Tisch Hospital, Rusk Rehabilitation, Hospital for Joint Diseases, Hassenfeld Children's Hospital of New York, and NYU Lutheran Medical Center) and more than 200 ambulatory locations across the New York metropolitan area. It also includes NYU School of Medicine, which since 1841 has trained thousands of physicians and scientists who have helped to shape the course of medical history. Our trifold mission to serve, teach, and discover is achieved daily through an integrated academic culture devoted to excellence in patient care, education, and research. Learn more about NYU Langone.
We have an exciting opportunity to join our team as a Senior Regulatory Specialist.
In this role, the successful candidate will be an integral member of the research teams and will assist with compliance with all regulators, institutional and departmental requirements, and programmatic support to clinical trials.
- Develop study procedures involving standard operation procedures.
- Monitor and facilitate study progress, ensure adherence to protocol. Update PI and Co-Investigators including problems.
- Knowledge of Good Clinical Practice (GCP), clinical research activities and guidelines related to consent, ethical conduct and protection of human subjects.
- Assist with the development and implementation of local protocols and grants (including study calendars, checklists, billing plans, letter of intents (LOIs), creation of case report forms (CRFs).
- Determine sponsor report requirements on industry supported clinical trials and establishing follow up systems to ensure compliance.
- Submit to and obtain approval from various in-house committees for initial request and any subsequent requests for re-approval.
- With investigator-initiated studies, assure the protocol and consent form conform to sponsor, Cancer Institute and NYU specifications.
To qualify you must have a Bachelor's Degree in Business Administration. A minimum of 2 years of comparable experience in hospital planning and operations; and a working knowledge of government codes/regulations is required. Knowledge of MS Office suites, database, spreadsheets, graphic and communications applications.Extensive knowledge of oncology clinical trials and oncology terminology required. Communication, analytical, presentation and time management skills are essential
Master's 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 Langone 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 Langone Medical Center 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 Langone Medical Center'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. To view the Pay Transparency Notice, please click here.