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 Senior Regulatory Specialist.
The Senior Regulatory Specialist will be responsible for programmatic support to initiate clinical trials. Reporting to the Senior Manager of Regulatory Affairs Unit, your specific responsibilities will include all pre-activation responsibilities. You will serve as the internal project manager for the specific oncology disease group(s) for which you are assigned and provide the group 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 and internal departments/ staff.
Uploading contracts & budgets in internal system (CDAs & CTAs) for completion by the appropriate legal department at NYU
Conduct Pre-study visits ensure site meets all requirements to conduct the clinical trial
Creation of regulatory master files for industry & investigator initiated oncology trials
Assisting with 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
Assist with organizing site initiation visits with sponsor/ CRO & clinical team
Assist the clinical team in the development of trial specific training tools for the study staff
Timely submission of all regulatory documents to ensure that activation timelines are met and tracks and controls regulatory submissions
Obtain initial approval from various committees (In-house: Scientific Committee, Institutional Review Board, Biosafety Committee, and Radiation Committee. External: FDA, NIH, NCI, Cooperative Groups)
Maintaining knowledge of Good Clinical Practice (GCP), clinical research activities and guidelines related to consent, ethical conduct and protection of human subjects
Aid in the development of departmental standard operation procedures
Minimum Qualifications: To qualify you must have a Bachelor's degree; Master's degree in a relevant discipline such as Public Health, Health Administration or a relevant science is highly desirable A minimum of 4 years or comparable experience in hospital planning and operations; and a working knowledge of government codes/regulations is required Excellent working knowledge of regulatory compliance requirements and procedures Knowledge of MS Office suites, database, spreadsheets, graphic and communications applications Extensive knowledge of oncology clinical trials and oncology terminology required 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
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 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 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. To view the Pay Transparency Notice, please click here.
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Internal Number: 61432111
About NYU Langone Health
NYU Langone Health, 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.nyulangone.org.