Lead Regulatory Affairs Research Specialist

2 weeks ago


New York, New York, United States NYU Langone Health Full time
Position Overview:
Join our esteemed team at NYU Langone Health as a Lead Regulatory Affairs Research Specialist. We are dedicated to enhancing the human experience through exceptional medical education, groundbreaking scientific research, and comprehensive patient care.

About Us:
NYU Grossman School of Medicine is recognized as one of the premier medical institutions in the nation. For over 175 years, we have been at the forefront of training physicians and scientists who have significantly impacted medical history and improved countless lives. Our commitment to equity, diversity, and inclusion is fundamental to our mission, fostering an environment where talented individuals from all backgrounds can thrive.

Key Responsibilities:
As a Lead Regulatory Affairs Research Specialist, you will:
1. Oversee the initiation of clinical trials, ensuring compliance with all regulatory requirements.
2. Manage contracts and budgets within our internal systems, coordinating with legal departments for timely completion.
3. Serve as the primary contact for local and national regulatory bodies, facilitating effective communication.
4. Conduct thorough pre-study assessments to confirm site readiness for clinical trials.
5. Develop and maintain regulatory master files for both industry-sponsored and investigator-initiated oncology trials.
6. Create patient informed consent documents for complex clinical studies, ensuring adherence to ethical standards.
7. Collaborate with investigators to prioritize and expedite the submission and activation of clinical trials.
8. Mentor junior regulatory staff, providing guidance and support in regulatory processes.

Qualifications:
To be considered for this role, candidates must possess:
- A Bachelor's degree in a relevant field.
- A minimum of 3 years of experience in oncology research, with a solid understanding of regulatory codes and requirements.
- Proficiency in MS Office and familiarity with database management and communication tools.
- Strong analytical, communication, and organizational skills.

Preferred Qualifications:
- A Master's degree in Public Health, Health Administration, or a related discipline.
- At least 4 years of experience in hospital planning and operations, with a comprehensive understanding of regulatory frameworks.

Why Join Us:
NYU Grossman School of Medicine offers more than just a job; we provide a supportive and enriching environment where you can contribute to meaningful work. We are an equal opportunity employer, committed to diversity and inclusion in all recruitment and employment practices. We encourage all qualified individuals to apply.

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