Research Regulatory Specialist

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 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 inclusion and individual skills, ideas, and knowledge. For more information, go tomed.nyu.edu, and interact with us on LinkedIn, Glassdoor, Indeed, Facebook, XandInstagram.Position Summary:We have an exciting opportunity to join our team as a Research Regulatory Specialist. The Research Regulatory Specialist will be responsible for programmatic support to initiate clinical trials within the Division of Endocrinology. Reporting to the Research Program Manager, your specific responsibilities will include pre- and post-activation responsibilities. You will serve as the internal regulatory specialist for the research projects to which you are assigned, including providing 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.Job Responsibilities: * Initiating contracts & budgets of clinical trials in the internal system (CDAs & CTAs) 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 division 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 endocrinology trials. * Develop trial specific patient informed consent forms for clinical trials * Contribute to the development and implementation of local protocols and grants (including consent forms, study calendars, letter of intents (LOIs)), and single patient INDs to ensure they conform to the sponsor & NYU specifications. * Organizing and preparing site initiation visits with sponsor/CRO & clinical team. * 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. Maintaining updates to regulatory documents and submitting modifications as needed. * 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 guidance to study members. * Maintaining knowledge of Good Clinical Practice (GCP), clinical research activities and guidelines related to consent, ethical conduct and protection of human subjects.Minimum Qualifications:To qualify you must have a Bachelors degree and at least 2 years of research experience. Excellent working knowledge of regulatory compliance requirements and procedures. Knowledge of MS Office suites, database, spreadsheets, graphic and communications applications. 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 Qualificat