| 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.
Job Responsibilities: - 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.  |
