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Research Regulatory Associate, Early Drug development

Vets Hired
New York, NY Full Time
POSTED ON 2/26/2025
AVAILABLE BEFORE 5/23/2025

About the job Research Regulatory Associate, Early Drug development

Role Overview :

We are seeking a dynamic clinical research professional to join the Early Drug Development service, supporting the phase 1 research team. The Research Regulatory Associate will be responsible for regulatory management tasks, ensuring that all regulatory documents and files are up-to-date and MSK is always audit-ready. The associate will also develop, revise, and maintain protocol tools to ensure the accurate conduct of clinical research and participate in special projects and task forces as needed.

Responsibilities :

  • Manage the regulatory aspects of research protocols, ensuring accuracy and compliance.
  • Keep regulatory documents and files up to date to ensure audit readiness.
  • Develop, revise, and maintain accurate protocol tools to support the accurate conduct of clinical research.
  • Participate in special projects and task forces as required.

Key Qualifications :

  • 2-4 years of experience in Clinical Research or Regulatory affairs.
  • Core Skills :

  • Extensive knowledge of regulations related to human subject protection (including 21 CFR and 45 CFR 46) and the Health Insurance Portability and Accountability Act (HIPAA).
  • Strong attention to detail and analytical skills.
  • Ability to plan and prioritize tasks to align with organizational goals.
  • Critical thinking and problem-solving skills to handle unforeseen issues efficiently.
  • Excellent communication skills, with the ability to engage professionally across all levels.
  • Enthusiasm and dedication to the organizations vision, mission, and values.
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