NYU School of Medicine is one of the nation's top-ranked medical schools. For 175 years, NYU 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 School of Medicine at its core is committed to improving the human condition through medical education, scientific research, and direct patient care. For more information, go to med.nyu.edu, and interact with us on Facebook, Twitter and Instagram.
Position Summary: We have an exciting opportunity to join our team as a Research Regulatory Assistant.
In this role, the successful candidate 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.
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 A minimum of 1 year or comparable experience in hospital planning and operations; and a working knowledge of government codes/regulations is required Extensive knowledge of oncology clinical trials and oncology terminology required
Qualified candidates must be able to effectively communicate with all levels of the organization.
NYU 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 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 or 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.
NYU Langone Medical Center, a world-class patient-centered integrated academic medical center, is one of the nation's premier centers for excellence in clinical care, biomedical research, and medical education. Located in the heart of Manhattan, NYU Langone is composed of four hospitals – Tisch Hospital, its flagship acute care facility; Rusk Rehabilitation; the Hospital for Joint Diseases, one of... only five hospitals in the nation dedicated to orthopaedics and rheumatology; and Hassenfeld Children's Hospital, a comprehensive pediatric hospital supporting a full array of children's health services across the medical center – plus the NYU School of Medicine, which since 1841 has trained thousands of physicians and scientists who have helped to shape the course of medical history. The medical center's tri-fold mission to serve, teach, and discover is achieved 365 days a year through the seamless integration of a culture devoted to excellence in patient care, education and research. For more information, go to www.NYULMC.org.