Key Responsibilities:
- Prepare, compile, and submit regulatory documents to IRBs/ECs.
- Support study start-up activities including vendor access and regulatory collection.
- Prepare documentation for SSVs, PSVs, and SIVs.
eRegulatory System Management & Migration:
- Support migration from Complion to Florence eRegulatory.
- Perform data entry, document cleanup, and QC during migration.
- Create and organize eISFs in Florence.
Required Skills & Competencies:
- Knowledge of ICH/GCP, FDA regulations, and HIPAA.
- Experience with eRegulatory systems (Florence preferred).
- Strong attention to detail and organization.
UniTriTeam
UniTriTeam is a global organization that supports 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.