Research Regulatory Associate Early Drug development
Research Regulatory Associate Early Drug development
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Salary Not Disclosed
1 Vacancy
Job Description
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 uptodate and MSK is always auditready. 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:
- 24 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 problemsolving 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.
Employment Type
Full Time
