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 an Assistant Manager - Research Regulatory.
In this role, the successful candidate facilitates the clinical trial start up process, regulatory submission and maintenance functions of the Cancer Clinical Trials Office (CTO). The Assistant Manager, Regulatory Affairs Unit, is responsible for the timely submission of all renewals and amendment submissions to local and federal entities. In addition, the Assistant Manager will aide in evaluating submission timelines and reporting on these metrics quarterly and annually, and for proposing resolutions to any bottlenecks identified.
A regulatory representative and professional resource for any site-specific projects or those submitted to the IRB.
Assist the Regulatory manager with study metrics and provides quarterly and annual reports on these metrics to be presented to Cancer Center leadership.
Ensures staff is in compliance with institutional SOPs, FDA regulations and Good Clinical Practice guidelines.
Ensures post-activation staff submits IRB annual renewals and obtains approval avoiding any lapses in approval.
Ensure staff submit amendments in a timely manner and communicate approval of amendments ensuring re-consenting occurs as required when necessary.
Serves as a resource to all regulatory staff to ensure streamlines processes and procedures.
Reviews all issues related to regulatory affairs as documented in monitoring and audit reports and ensure prompt resolution and future prevention of such findings.
Personnel Management of all post activation regulatory support staff including training and professional development and participates in the development of training programs specific to staff.
Liaison with Institutional Review Board to ensure quick turnaround of review and approval on all submissions.
Ensure staff is appropriately educated on federal regulations governing human subjects research.
Performs all other duties as assigned.
Minimum Qualifications: Bachelor's degree and 3-5 years of experience in regulatory affairs in a management position Full understanding or Federal Regulations & GCP Guidelines governing the conduct of human research Knowledge of MS Office suites, database, spreadsheets, graphic and communications applications Exceptional communication, analytical, presentation and time management skills
Preferred Qualifications: Masters degree
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: 60441677
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.