Assistant Director - Regulatory Affairs * Will Offer Relocation Assistance *
NYU Langone Medical Center
Location: New York/NY/USA
Required Education: High School
Internal Number: 98749111
NYU Grossman School of Medicine is one of the nation's top-ranked medical schools. For 175 years, NYU Grossman 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 Grossman 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 LinkedIn, Glassdoor, Indeed,Facebook, Twitter and Instagram.
We have an exciting opportunity to join our team as an Assistant Director - Regulatory Affairs. The Regulatory Affairs Unit facilitates the clinical trial start up process as well as all regulatory submission and maintenance functions of the Cancer Clinical Trials Office (CTO). The Assistant Director of Regulatory Affairs Unit is responsible for the timely study startup of all clinical trials, as well as the timely submission of all continuing renewals and amendment submissions. In addition, the Assistant Director is responsible for evaluating submission timelines and reporting on these metrics quarterly and annually, and for proposing resolutions to any bottlenecks holding up the approval process. The Assistant Director will oversee all managers responsible for regulatory oversight and provide indirect oversight over all regulatory staff.
1. Serves as the regulatory representative and professional resource for any site-specific projects or those submitted to the IRB.
2. Interacts on behalf of principal investigators or the IRB with sponsors, research institutions, contract research organizations, regulatory agencies, and involved institutional departments.
3.Defines study start up metrics and provides quarterly and annual reports on these metrics to be presented to Cancer Center leadership.
4.Ensures staff compliance with institutional SOPs, FDA regulations and Good Clinical Practice guidelines.
5. Ensures staff submits IRB annual renewals and obtains approval avoiding any lapses in approval.
6. Work with all units within the office, ancillary services and other departments to improve processes and activation timelines
7. Ensure staff submit amendments in a timely manner and communicate approval of amendments ensuring re-consenting occurs as required when necessary.
8. Ensures staff conducts all study activation activities in line with targeted timelines for study start up.
9. Serves as a resource to all regulatory staff to ensure streamlines processes and procedures.
10. Reviews all issues related to regulatory affairs as documented in monitoring and audit reports and ensure prompt resolution and future prevention of such findings.
11. Participates in the development of training programs specific to regulatory staff.
12. Personnel Management of all pre activation and post activation regulatory support staff including training and professional development.
13. Liaison with Quality Assurance and IIT Support Unit as needed regarding IND and IDE applications to the FDA.
14. Ensure appropriate communications to Disease Management Groups regarding status of pipeline and active studies.
15. Ensure staff is appropriately educated on federal regulations governing human subjects research.
16. Liaison with Institutional Review Board to ensure quick turnaround of review and approval on all submissions.
17. Provides regulatory leadership support across the enterprise.
18. Develop and run reports to ensure compliance and process improvement
19. Lead or participate in IT projects related to the Regulatory Affairs Unit
20. Development and revision of SOPs.
21. Performs all other duties as assigned.
To qualify you must have a Bachelors Degree. 8+ years of experience in clinical research. 3+ years of regulatory experience. 2+ years of direct management experience. Full understanding of Federal Regulations and GCP Guidelines governing the conduct of human subjects research. Knowledge of MS Office suites, database, spreadsheets, graphic and communications applications. Exceptional communication, analytical, presentation and time management skills.
Masters degree. CCRC or CCRP certification with SOCRA or ACRP. Experience working in a NCI Designated Comprehensive Cancer Center. 5+ years of regulatory experience. 4+ years of direct management.
Qualified candidates must be able to effectively communicate with all levels of the organization.
NYU Grossman 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 Grossman 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 Grossman 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.
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.