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Responsibilities:
- Prepare FDA 1572s, FDFs, PSPs, and IB acknowledgments
- Ensure all documents are audit-ready and accurately filed
- Support study start-up activities including vendor access and regulatory collection
Required Skills:
- Knowledge of ICH/GCP, FDA regulations, and HIPAA
- Strong attention to detail and organization
- Ability to manage multiple timelines
Education & Experience:
- High school diploma required; Bachelor’s preferred
- 2+ years of clinical research regulatory experience required
- Florence eRegulatory experience preferred
UniTriTeam
UniTriTeam is a global organization supporting clinical research sites and organizations through staff augmentation and technology solutions. They pride themselves on creating opportunities for their team members while delivering exceptional results for their clients.