Regulatory Specialist – Study Start-Up

Job description

**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 Performance. We are a global organization supporting clinical research sites and organizations through staff augmentation and technology solutions. We pride ourselves on creating opportunities for our team members while delivering exceptional results for our clients. **What We Offer:** - 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