Research Regulatory Specialist

  • New York, NY

Employment Type

: Full-Time

Industry

:



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 Research Regulatory Specialist.



An integral member of the research team and in compliance with all regulatory institutional and departmental requirements, the incumbent will be responsible for programmatic maintenance support of clinical trials. Reporting to the Senior Manager of Regulatory Affairs Unit, your specific responsibilities will include all post-activation responsibilities. You will serve as a liaison between the sponsor, CRO, IRB and internal departments/staff.

Job Responsibilities:

  • 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
  • Meet & correspond with sponsor and/ or CROs during monitoring visits and ensure study regulatory files are up to date & audit ready
  • 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

Minimum Qualifications:
To qualify you must have a Bachelor's degree..
A minimum of 1-2 years or comparable experience in hospital planning and operations; and a working knowledge of government codes/regulations is required.
Extensive knowledge of oncology clinical trials and oncology terminology required.
Knowledge of MS Office suites, database, spreadsheets, graphic and communications applications.
Exceptional communication, analytical, presentation and time management skills.

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.

Position Summary:
An integral member of the research team and in compliance with all regulatory institutional and departmental requirements, the incumbent will be responsible for programmatic maintenance support of clinical trials. Reporting to the Senior Manager of Regulatory Affairs Unit, your specific responsibilities will include all post-activation responsibilities. You will serve as a liaison between the sponsor, CRO, IRB and internal departments/staff.

Minimum Qualifications:
Bachelor's degree..
A minimum of 1-2 years or comparable experience in hospital planning and operations; and a working knowledge of government codes/regulations is required.
Extensive knowledge of oncology clinical trials and oncology terminology required.
Knowledge of MS Office suites, database, spreadsheets, graphic and communications applications.
Exceptional communication, analytical, presentation and time management skills.




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