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.