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Regulatory Manager - IVF/Manhattan

NYU Langone Health
United States, New York, New York
June 23, 2022

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 Linked In, Glassdoor, Indeed, Facebook, Twitter and Instagram.

Position Summary:
We have an exciting opportunity to join our team as a Regulatory Manager - IVF.

In this role, the successful candidate will be responsible for developing, implementing and monitoring quality practices through audit tools and other protocols for all patients at the FC to ensure policies adhere to FDA, NYSDOH, AAAASF, FDNY and other regulatory bodies.

Job Responsibilities:

    • Initiate, coordinate, facilitate all research documentation and policies and procedures at NYULMC FC in accordance with policies of the NYULMC Office of Research, Good Clinical Practices, HIPAA and required obligations to patient/subject and sponsor.
    • All relevant duties assigned.
    • Assist Laboratory Director in obtaining necessary licenses and permits required by NYSDOH and FDA.
    • Maintain record tracking of medical equipment preventive maintenance schedules for the American Association for Accreditation of Ambulatory Surgery Facilities (AAAASF)
    • Review data and documentation relative to SART/ FDA/CDC/NYSDOH requirements. Provide education and resource tools for all staff related to existing, new and emerging technologies compliance and regulation, and all research studies;
    • Conduct internal audit reviews for the laboratory, nursing and donor egg program.
    • Establish and monitor system to monitor and distribute patient consents and waivers for Fertility Center and at its satellite Programs
    • Assist Laboratory Director in preparing, editing, and updating SOPMs for NYUFC and its satellite Laboratories for the following: NYSDOH for the Andrology and Endocrinology Laboratory; New York State Dept. of Health (NYSDOH) for the Gamete Bank (sperm and oocyte donation programs); Food and Drug Administration (FDA) for Gamete Donation, and (when required) for Nursing.
    • Establish and maintain lines of communication with NYUSOM IRB, and research departments.
    • Coordinate and track research specimens that are shipped out to Reference Laboratories and review and record results
    • Manage patient consents for standard of care for the FC, interface with legal on development and implementation of amendments
    • Produce monthly/quarterly quality assurance projects/audit reports for all patient care and staff safety activities.
    • Acts as liaison to all inspectors/surveyors of laboratories for NYC, NYSDOH, FDA and clinical monitors for research activities.
    • Develop, implement and monitor quality practices through audit tools and other protocols for all patients at the FC to ensure policies adhere to FDA, NYSDOH, AAAASF, FDNY and other regulatory bodies.
    • Coordinate research activities conducted at NYUFC including IRB application submissions, e.g., for new protocols including initiating all studies for the fertility center, continuations, amendments plus subject recruitment; assist in protocol and consent preparation and preparing study source documents; data collection; serve as liaison between principal investigators and clinical staff; and assist in budget/billing plan proposals for industry-sponsored clinical trial agreements; NIH study budget preparation for Sponsored Programs Administration (SPA) office.

Minimum Qualifications:
To qualify you must have five years experience in clinical and research operations developing quality assurance programs, standard operating procedures, interfacing with institutional, government and regulatory bodies related to patient and staff safety. Experience in Assisted reproductive technologies, with demonstrated understanding of Donor gametes, gamete quarantine, infectious disease testing, fertility preservation techniques, chain of custody and legal requirements for all processing. Bachelor's Degree in science or health care administration. Advanced training in IRB and Quality measures. Expert in document development and editing

Preferred Qualifications:
Masters degree in Healthcare Administration or other relevant course of study ASCP or AAB designation.

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.

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