, New York

NYU Langone Health

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. At NYU Langone Health, equity, diversity, and inclusion are fundamental values. We strive to be a place where our exceptionally talented faculty, staff, and students of all identities can thrive. We embrace diversity, inclusion, and individual skills, ideas, and knowledge. For more information, go to med.nyu.edu, and interact with us on LinkedInGlassdoorIndeed, FacebookTwitter and Instagram.

Position Summary:

Reporting to the Assistant Director of Regulatory Affairs in the Regulatory Affairs and Business Operations (RABO) unit of the Office of Science and Research (OSR), the Manager will be responsible for overseeing the registration and maintenance of studies on ClinicalTrials.gov. The Manager is also responsible for supporting the Assistant Director in FDA-related work (e.g., Investigational New Drug (IND) and Investigational Device Exemption (IDE) applications) and managing the iConnect suite of clinical research utilities. The Manager will work in coordination with the Regulatory Affairs team (Assistant Director and Specialist).

Job Responsibilities:

. Oversee centralized ClinicalTrials.gov registration, annual record verification, and results reporting processes.
. Support the Assistant Director with the development and coordination of FDA submissions, including Investigational New Drug Applications (INDs), Investigational Device Exemption (IDE) Applications, and Pre-Submission Requests.
. Monitor, analyze and facilitate the implementation of new and revised regulatory requirements.
. Review and maintain OSR standard operating procedures (SOPs) for clinical research, including IND/IDE SOPs.
. Manage administration of the iConnect suite of clinical research utilities, including posting of studies on the clinical trials registry and tracking of referrals.
. Perform preliminary troubleshooting when iConnect issues are encountered. For issues that require attention from the IT / iConnect team, submit tickets.
. Maintain IRB approval of the iConnect volunteer registry.
. Develop and execute the Regulatory Affairs educational program consisting of individual and group training sessions on topics such as ClinicalTrials.gov, iConnect, IND/IDEs, etc. to facilitate compliance with regulations, federal guidance, and institutional policies and SOPs.
. Provide support and assistance for any additional work and special projects as required by the Assistant Director and Director of Regulatory Affairs and Business Operations.
. Maintain education and training to ensure current and up to date knowledge for all job-related aspects.
. Participate in ongoing training and process evaluation as needed.

Minimum Qualifications:

To qualify you must have a

  • Bachelor's Degree in biomedical or social/behavioral sciences or a related field;
  • Three years’ experience in clinical research and/or IRB/regulatory work;
  • Demonstrated knowledge of federal regulations and FDA guidance as related to INDs and IDEs;
  • Must exercise a high degree ofindependent judgment and discretion relating to research protocol issues;
  • Superior organizational, analytical, timemanagement, multi-tasking and interpersonal communication skills;
  • Excellent verbal and technical writing skills and proficient use of computer and relevant software applications (IRB software, MS Word, MS Excel, MS PowerPoint,).

Preferred Qualifications:

  • Certification in a related field (e.g., CIP, ACRP, etc.);
  • Master’s Degree in biomedical or social/behavioral sciences or a related field

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 City Law on Salary Transparency in Job Advertisements. The salary range for the role is $88,524.96 - $92,700.00 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

, New York

NYU Langone Health, a world-class, patient-centered, integrated academic medical center, is one of the nation’s premier centers for excellence in clinical care, biomedical research, and medical education. Located in the heart of Manhattan, NYU Langone is composed of five hospitals—Tisch Hospital, its flagship acute care facility; Rusk Rehabilitation; the Hospital for Joint Diseases, the Medical Center’s dedicated inpatient orthopaedic hospital; NYU Lutheran Medical Center, a full-service, 450-bed teaching hospital located in Brooklyn, and Hassenfeld Children’s Hospital, a comprehensive pediatric hospital supporting a full array of children’s health services across the Medical Center. Also, part of NYU Langone is NYU School of Medicine, which since 1841 has trained thousands of physicians and scientists who have helped to shape the course of medical history, and the Laura and Isaac Perlmutter Cancer Center, a National Cancer Institute–designated cancer center. The Medical Center’s trifold mission to serve, teach, and discover is achieved 365 days a year through the seamless integration of a culture devoted to excellence in patient care, education, and research.

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