NYU Langone Medical Center
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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, FDA and internal departments/ staff.
- Aid in the development of departmental standard operation procedures.
- Maintaining knowledge of Good Clinical Practice (GCP), clinical research activities and guidelines related to consent, ethical conduct and protection of human subjects.
- Mentor junior regulatory staff.
- Provide regulatory counsel and guidance to study members.
- Prepare, submit and obtain initial approval from mandatory scientific review committees (In-house: Protocol Review and Monitoring Committee, Institutional Review Board, Biosafety Committee, Conflicts of Interest Committee and Radiation Committee. External: FDA, NIH, NCI, Cooperative Groups).
- Timely submission of all regulatory documents to ensure that activation timelines are met and track and control all regulatory submissions and disseminate approvals.
- Collaborate with investigators to prioritize the submission and activation of clinical trials.
- Assist the clinical team in the development of trial specific training tools for the study staff.
- Organizing and preparing site initiation visits with sponsor/CRO & clinical team.
- Contribute to 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.
- Develop trial specific patient informed consent forms for highly complex clinical trials (phase 0, 1, 1/2, 2, and 3).
- Creation of regulatory master files for industry & investigator initiated oncology trials.
- Conduct pre-study visits to ensure site meets all requirements to conduct the clinical trial are met.
- Complete site qualification questionnaires from potential industry sponsors and analyze PCC ability to participate.
- Directly communicate with local and national regulatory authorities.
- Initiating contracts & budgets of clinical trials in the internal system (CDAs & CTAs) for completion by the appropriate legal department at NYU and managing their completion to ensure timely activation.
To qualify you must have a Bachelor's degree. 3 years of research related experience in oncology; 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.
Master's degree in a relevant discipline such as Public Health, Health Administration or a relevant science is highly desirable. Minimum of 4 years or comparable experience in hospital planning and operations; and a working knowledge of government codes/regulations is required.
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.
Employment/Position Type:Full Time
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