Regulatory Affairs Associate
$41,600–$58,240 year
On-site · Staten Island, New York, United States
Job Summary
Regulatory Affairs Assistant to support regulatory submission targets, maintain regulatory documents, assist with Investigator Site File setup, collect signatures, monitor logs, and ensure compliance with GCP/ICH/HIPAA. Role reports to Regulatory Manager or Site Director; involves archival of study documents and ongoing training in SOPs/WIs. Two-year degree preferred; part-time position based in Staten Island, NY. Proficiency with clinical research processes and regulatory documentation is required.
Required Qualifications
- High School Diploma or its equivalent; Two-year degree preferred.
- Clinical Research experience preferred but not required.
- Working knowledge of medical terminology and the clinical research process
- Attention to detail
- Organizational Skills
- Strong computer skills, including Microsoft Office
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