UniTriTeam
Regulatory Specialist – Study Start-Up
RemoteBrazil only· UTC-5…UTC-5
- Role
- Operations
- Experience
- Mid
Salary not disclosed
Check eligibility
Open to BR only · UTC-5…UTC-5. Set where you work from to check your eligibility.
No BS summary
Regulatory specialist with 2+ years of clinical research regulatory experience. Must know ICH/GCP, FDA regulations, HIPAA, and eRegulatory systems; Florence is preferred. Role works Eastern Standard Time hours and supports study start-up plus Complion-to-Florence migration.
Core skills
eRegulatory systemsFlorence eRegulatory
Required skills
ICH/GCPFDA regulationsHIPAA
What you'll do
- 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
- Support migration from Complion to Florence eRegulatory
- Perform data entry, document cleanup, and QC during migration
- Create and organize eISFs in Florence
- Ensure all documents are audit-ready and accurately filed
- Prepare FDA 1572s, FDFs, PSPs, and IB acknowledgments
- Route documents for signatures and follow up for completion
- Maintain CVs, licenses, and GCP documentation
- Partner with coordinators, investigators, and sponsors
- Track timelines and proactively resolve delays
What they require
- Knowledge of ICH/GCP, FDA regulations, and HIPAA
- Experience with eRegulatory systems (Florence preferred)
- Strong attention to detail and organization
- Ability to manage multiple timelines
- Strong communication skills
- High school diploma required; Bachelor’s preferred
- 2+ years of clinical research regulatory experience required
- Florence eRegulatory experience preferred
- Current GCP certification preferred
Benefits
- Flexible, remote-friendly work environment
- Opportunity to grow into full-time role and expand responsibilities
- Exposure to global clinical research operations and technology
- Hands-on experience with leading platforms such as Florence eRegulatory
- Collaborative, high-growth, and entrepreneurial environment
- Ongoing professional development and training opportunities
UniTriTeam is a global organization supporting clinical research sites and organizations through staff augmentation and technology solutions.
Healthcare
Details
Apply routeGreenhouse
Salary not disclosed