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Research Regulatory Coordinator

NYU Langone

Research Regulatory Coordinator

2 locations
Full Time
Paid
  • Responsibilities

    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 LinkedInGlassdoorIndeedFacebookTwitter and Instagram.

     

    POSITION SUMMARY:

    We have an exciting opportunity to join our team as a Research Regulatory Coordinator.

    NYU Langone Health is the Clinical Science Center (CSC) for a major NIH grant to study Post-Acute Sequelae of SARS-CoV-2 Infection (PASC) or Long COVID. This 4 year initiative aims to answer key research questions needed to advance the scientific communitys understanding of Long COVID and discover effective therapeutics to address it. The Regulatory Coordinator position is part of the Clinical Science Core (CSC) whose purpose is to coordinate the development and implementation of master protocols; to provide expertise in clinical protocol design, implementation; and execution of large clinical research studies for the PASC grant. This is an interdepartmental effort that spans the Office of Science and Research, Department of Medicine, Department of Population Health and Medical Center IT.

     

    The Regulatory Coordinator will serve as the internal coordinator for the specific disease group(s) assigned and provide the group timely updates on the status of submissions and regulatory guidance on study development.

     

    JOB RESPONSIBILITIES:

     

    • Aid in the development of departmental standard operation procedures
    • Maintain knowledge of Good Clinical Practice (GCP), clinical research activities and guidelines related to consent, ethical conduct and protection of human subjects
    • Prepare, submit and obtain initial approval from mandatory scientific review committees (In-house: Protocol Review and Monitoring Committee, and Institutional Review Board. External: 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
    • Work with central IRB to obtain approval for the sites that do not use a local IRB and will work with sites and NYU legal contract specialist on site and other subcontractors
    • Certify sites for enrollment by reviewing and approving all necessary documents prior to the site enrolling
    • Obtain NYU Institutional Review Board approval for the CSC functions.  Approval will be for the protocol and any amendments and approval of the consent template to be sent to sites 
    • Obtain yearly NYU IRB approval for the CSC functions
    • Send all site central and local IRB/EC approvals to the NYU IRB
    • Assist in the development of clinical trial agreement template in collaboration with the institution which outlines the obligations of the site investigator and payment to the site
    • Negotiate contracts utilizing Program Director and attorney for support
    • Send contract to sites for review by institution
    • Review all revisions made by site and obtain sponsor and institution approval for any revisions
    • Identify clear site payment milestones, in collaboration with Program Director, primarily focused on completion of data entry and query resolution by sites to enhance enrollment, completion of critical visits, and data cleaning
    • Follow up with sites regarding contract status to expedite site start-up
    • Amend site contracts as needed
    • Other duties as assigned

     

    MINIMUM QUALIFICATIONS:

    To qualify you must have a Bachelor's Degree in a scientific field, business, healthcare administration or a related field and at least 2 years experience in academic or other clinical research environment, or related area with demonstrated analysis and facilitation skills

     

    PREFERRED QUALIFICATIONS:

    Experience managing multi-site studies, and working with large and diverse networks of clinical research sites is preferred. Experience and knowledge of applicable regulations and guidance documents.

     

    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.

    Required Skills Required Experience

  • Locations
    New York, NY • New York, NY