Advanced Regulatory Affairs Specialist

2 weeks ago

New York, New York, United States NYU Langone Full time

NYU Langone Health is a leading institution in medical education and research, dedicated to enhancing the human condition through innovative healthcare solutions. Our commitment to equity, diversity, and inclusion is at the forefront of our mission, fostering an environment where talented individuals from all backgrounds can excel.

Position Overview:

We are pleased to announce an opportunity for an Advanced Regulatory Affairs Specialist. In this pivotal role, the selected candidate will provide essential programmatic support for the initiation of clinical trials. Reporting directly to the Senior Manager of the Regulatory Affairs Unit, you will oversee all pre-activation tasks. You will act as the internal project coordinator for designated oncology disease groups, ensuring timely updates on submission statuses and offering regulatory guidance throughout study development. Furthermore, you will facilitate communication between sponsors, CROs, IRBs, the FDA, and internal departments.

Key Responsibilities:

  • Manage the initiation of contracts and budgets for clinical trials within the internal system, ensuring timely completion by the appropriate legal departments.
  • Engage directly with local and national regulatory bodies.
  • Complete site qualification questionnaires from potential industry sponsors and assess the site's capability to participate.
  • Conduct pre-study visits to confirm that all requirements for conducting clinical trials are met.
  • Create regulatory master files for both industry-sponsored and investigator-initiated oncology trials.
  • Develop trial-specific informed consent forms for complex clinical trials (phases 0, 1, 1/2, 2, and 3).
  • Contribute to the formulation and execution of local protocols and grants, ensuring compliance with sponsor and institutional specifications.
  • Organize and prepare for site initiation visits in collaboration with sponsors, CROs, and clinical teams.
  • Assist the clinical team in crafting trial-specific training materials for study staff.
  • Collaborate with investigators to prioritize the submission and activation of clinical trials.
  • Ensure timely submission of all regulatory documents to meet activation timelines and track all submissions, disseminating approvals as necessary.
  • Prepare and submit documents for initial approval from required scientific review committees.
  • Provide regulatory guidance and support to study team members.
  • Mentor junior regulatory staff.
  • Maintain up-to-date knowledge of Good Clinical Practice (GCP) and clinical research guidelines.
  • Assist in developing departmental standard operating procedures.

Minimum Qualifications:

To be considered for this role, candidates must possess a Bachelor's degree and have a minimum of three years of research experience in oncology, along with a solid understanding of relevant government regulations. Proficiency in regulatory compliance requirements, MS Office applications, and a comprehensive knowledge of oncology clinical trials is essential. Candidates should demonstrate exceptional communication, analytical, and time management skills.

Preferred Qualifications:

A Master's degree in a relevant field such as Public Health or Health Administration is highly desirable, along with at least four years of experience in hospital planning and operations.

NYU Langone Health is an equal opportunity employer, committed to diversity and inclusion in all aspects of recruitment and employment.

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