Research Regulatory Specialist

NYU Langone Health•New York, NY

1d•$66,300 - $81,249•Onsite

About The Position

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.

Requirements

Bachelors degree
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.
Qualified candidates must be able to effectively communicate with all levels of the organization.

Nice To Haves

Masters degree in a relevant discipline such as Public Health, Health Administration or a relevant science is highly desirable.

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.