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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.
Performs all other duties as assigned.
Ensure staff is appropriately educated on federal regulations governing human subjects research.
Liaison with Institutional Review Board to ensure quick turnaround of review and approval on all submissions.
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.
Reviews all issues related to regulatory affairs as documented in monitoring and audit reports and ensure prompt resolution and future prevention of such findings.
Serves as a resource to all regulatory staff to ensure streamlines processes and procedures.
Ensure staff submit amendments in a timely manner and communicate approval of amendments ensuring re-consenting occurs as required when necessary.
Ensures post-activation staff submits IRB annual renewals and obtains approval avoiding any lapses in approval.
Ensures staff is in compliance with institutional SOPs, FDA regulations and Good Clinical Practice guidelines.
Assist the Regulatory manager with study metrics and provides quarterly and annual reports on these metrics to be presented to Cancer Center leadership.
A regulatory representative and professional resource for any site-specific projects or those submitted to the IRB.
Minimum Qualifications: To qualify you must have a Bachelor's degree and 3-5 years of experience in regulatory affairs. 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: 69261593
About NYU Langone Medical Center
NYU Langone Health is a world-class, patient-centered, integrated academic medical center, known for its excellence in clinical care, research, and education. Included in the 200+ locations throughout the New York area are five inpatient locations: Tisch Hospital, its flagship acute-care facility; Rusk Rehabilitation, ranked as one of the top 10 rehabilitation programs in the country; NYU Langone Orthopedic Hospital, a dedicated inpatient orthopedic hospital with all musculoskeletal specialties ranked top 10 in the country; Hassenfeld Children's Hospital at NYU Langone, a comprehensive pediatric hospital supporting a full array of children's health services; and NYU Langone Hospital—Brooklyn, a full-service teaching hospital and level 1 trauma center located in Sunset Park, Brooklyn. Also part of NYU Langone Health is the Laura and Isaac Perlmutter Cancer Center, a National Cancer Institute–designated cancer center, and NYU School of Medicine, which since 1841 has trained thousands of physicians and scientists who have helped to shape the course of medical history.