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Position Summary:
We have an exciting opportunity to join our team as a Senior Research Regulatory Specialist. The Senior Regulatory Specialist will be responsible for programmatic support to initiate clinical trials. Reporting to the 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. The Senior Regulatory Specialist will be responsible for ongoing maintenance of essential documents, IRB submissions and communication with the sponsor throughout the course of the study until study termination. You will also provide mentorship and onboard to Regulatory Assistants and Regulatory Specialists.
Job Responsibilities:
Initiating contracts & budgets of clinical trials in the internal system (CDA’s & CTA’s) for completion by the appropriate legal department at NYU and managing their completion to ensure timely activation.
Directly communicate with local and national regulatory authorities.
Complete site qualification questionnaires from potential industry sponsors and analyze PCC ability to participate.
Conduct pre-study visits to ensure site meets all requirements to conduct the clinical trial are met.
Creation of regulatory master files for industry & investigator initiated oncology trials.
Develop trial specific patient informed consent forms for highly complex clinical trials (phase 0, 1, 1/2, 2, and 3).
Contribute to the development and implementation of local protocols and grants (including consent forms, study calendars, letter of intents (LOIs)), and single patient IND’s to ensure they conform to the sponsor & NYU specifications.
Organizing and preparing site initiation visits with sponsor/CRO & clinical team.
Assist the clinical team in the development of trial specific training tools for the study staff.
Collaborate with investigators to prioritize the submission and activation of clinical trials.
Timely submission of all regulatory documents to ensure that activation timelines are met and track and control all regulatory submissions and disseminate approvals.
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).
Provide regulatory counsel and guidance to study members.
Mentor junior regulatory staff.
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.
Maintenance of regulatory master files for industry & investigator initiated oncology trials
Submission of study amendments in a timely fashion including changes to the protocol, consent forms and other study documents.
Accurate preparation of annual renewals & study closure for IRB & sponsors.
Upload any contractual or budgetary changes in internal system for completion by appropriate department at NYU
Assist the clinical team with the development and implementation of amendments
Obtain continuing approvals from various committees and organizations (In-house: Scientific Committee, Institutional Review Board, Biosafety Committee, Radiation Committee.
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 protocol specific standard operation procedures
Provide mentorship and training to junior regulatory staff
Provide regulatory coverage for other Disease Management Groups as need
Participate audits conducted through the internal audit committee
Participate in workgroups and SOPs related to regulatory processes and workflows
Perform additional duties as required
Minimum Qualifications:
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.
Preferred Qualifications:
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.
NYU Langone Health provides a salary range to comply with the New York state Law on Salary Transparency in Job Advertisements. The salary range for the role is $67,771.14 - $96,515.12 Annually. Actual salaries depend on a variety of factors, including experience, specialty, education, and hospital need. The salary range or contractual rate listed does not include bonuses/incentive, differential pay or other forms of compensation or benefits.
To view the Pay Transparency Notice, please click here
Required Skills
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