Location: Eastern Standard Time Hours
Position Overview
UniTriTeam is seeking a detail-oriented and proactive Regulatory Specialist – Study Start-Up to support our client in executing efficient, compliant study start-up activities across their clinical trial portfolio.

This role is dedicated to accelerating study activation timelines while also supporting a critical migration from Complion to Florence eRegulatory. The role will include regulatory start-up execution, as well as data entry, document cleanup, and quality control activities to ensure a seamless transition to Florence.
Key Responsibilities
Study Start-Up & Regulatory Submissions
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
Ensure all documents are audit-ready and accurately filed




Regulatory Documentation Preparation
Prepare FDA 1572s, FDFs, PSPs, and IB acknowledgments
Route documents for signatures and follow up for completion
Investigator & Site Credential Management
Maintain CVs, licenses, and GCP documentation
Collaboration & Execution
Partner with coordinators, investigators, and sponsors
Track timelines and proactively resolve delays
Required Skills & Competencies
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
Education & Experience
High school diploma required; Bachelor’s preferred
2+ years of clinical research regulatory experience required
Florence eRegulatory experience preferred
Current GCP certification preferred
Why Join UniTriTeam
At UniTriTeam, we are powered by People, Passion, and P

📌 Regulatory Specialist – Study Start-Up (Lima)
🏢 Indeed
📍 Lima