Brian O

Study Coordinator

National Health Service (NHS) • Part time

Jul 2025 - Present • 1 yr 3 mos

Independently managing a portfolio of 20–55 pharmaceutical-sponsored Phase II–IV respiratory trials within a high-performing Commercial Research Delivery Centre (CRDC). Leading end-to-end study set-up (feasibility, IRAS/HRA submissions, contracts liaison, site file governance), reducing time-to-activation by ~25% through proactive stakeholder coordination. Primary administrative liaison for global pharma sponsors and CROs, consistently delivering ≥100% recruitment targets and meeting contractual milestones. Utilised Cerner Millennium (EPR) to support complex eligibility screening and accelerate recruitment, improving time-to-first patient by 2–4 weeks per study. Maintaining full lifecycle oversight in EDGE Clinical Research Management System, ensuring real-time recruitment, finance attribution, and milestone accuracy — achieving zero critical audit findings. Supporting commercial income tracking in line with AcoRD guidance, contributing to recovery of millions of annual research revenue. Ensure 100% compliance with ICH-GCP, MHRA, and NHS R&D governance standards, maintaining continuous audit and inspection readiness. Producing performance dashboards for CRDC leadership and NIHR reporting, contributing to 15%+ year-on-year portfolio growth. Mentoring junior administrators and contribute to workflow improvements, reducing administrative turnaround times by 20%+. Coordinating and supporting key clinical trial milestones, including Site Initiation Visits (SIVs), routine monitoring visits, and Close-Out Visits (COVs), by preparing essential study documentation, facilitating sponsor and CRO interactions, resolving action items, and maintaining delegation logs, training records, and Trial Master File (TMF)/Investigator Site File (ISF) documentation to ensure continuous inspection readiness and full ICH-GCP compliance.