Gerard Gomes
Senior Clinical Research Leader | Decentralized Trial Operations & Patient Recruitment | eCOA Implementation | NASH Specialist | Published Researcher | Open to Director Roles
- Role
- Senior Clinical Research Coordinator Hepatology at Ochsner Health
- Location
- New Orleans, LA, US
- LinkedIn followers
- 500 followers
Experience
Senior Clinical Research Coordinator Hepatology
Oct 2024 — Present · New Orleans, LA, US
Leading clinical trial operations for Phase 2-3 NASH and hepatology studies with focus on patient recruitment optimization, digital health integration, and remote trial methodologies. DIGITAL HEALTH & eCOA IMPLEMENTATIONImplemented AiCure eCOA platform for AKERO-105 NASH trial, coordinating digital patient-reported outcomes collection, training site staff on mobile application usage, and ensuring protocol compliance for remote data capture. Pioneered use of consumer-grade technology for clinical trial endpoints, directly supporting decentralized trial execution models. ENROLLMENT BREAKTHROUGHRevitalized dormant Phase 3 NASH trial by enrolling first participant in 2+ years through strategic physician engagement and systematic patient identification from FibroScan screening databases. Overcame enrollment barriers in highly competitive therapeutic area through process innovation and stakeholder collaboration. HIGH-VOLUME SCREENING OPERATIONSBuilt screening infrastructure processing 500+ pre-screenings for AFFIRM and AKERO-105 studies, creating efficient patient pipelines that improved clinic coordination and accelerated enrollment readiness. Developed tracking systems enabling real-time enrollment forecasting and bottleneck identification. DATA QUALITY & COMPLIANCEEnhanced sponsor confidence by resolving 400+ outstanding data queries for MGL-011 study, ensuring regulatory compliance and maintaining audit-ready documentation standards. Implemented quality control processes that reduced query generation rates and improved monitoring visit outcomes.🤝 CROSS-FUNCTIONAL LEADERSHIPStrengthened partnerships with hepatology providers, transplant teams, pharmacy, and diagnostic services to integrate research seamlessly into clinical workflows. Served as liaison between clinical operations and research teams, facilitating enrollment opportunities and improving patient access to trials.
Education
University of Richmond
Bachelor of Science (B.S.), Biochemistry and Molecular Biology
2004 — 2008
Tulane University Celia Scott Weatherhead School of Public Health and Tropical Medicine
Master of Public Health - MPH, Epidemiology
Skills
- Hiv Prevention
- Policy Analysis
- Microsoft Office
- International Relations
- Grants
- Public Speaking
- Community Outreach
- Community Development
- Global Health
- Community Organizing
- Program Evaluation
- Program Development
- Nonprofits
- Intercultural Communication
- Ngos
- Youth Development
- Grant Writing
- French
- Research
- Capacity Building
- International Development
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