Teams at ProTrials Research, Inc.

Leads clinical trial operations from inception through completion, managing timelines, budgets, monitoring, vendors, clinical supplies, data collection, risks, resources, training, and project plans. Serves as the primary sponsor contact, coordinates cross-functional teams, ensures GCP and regulatory compliance, oversees deliverables, and mentors team members. Requires strong communication, organization, leadership, virtual project-management experience, prior multifaceted study management, and proficiency with Microsoft Office.

Monitors and manages clinical trials through site qualification, initiation, interim, and close-out visits. Trains site personnel, oversees investigational product inventory, reviews source data and regulatory documentation, resolves data discrepancies, tracks safety and enrollment issues, maintains study files, and supports junior CRAs. The role requires strong knowledge of FDA regulations, ICH GCP, clinical research practices, and frequent travel of up to 65%.

Leads CRA and CTA teams across clinical studies, overseeing monitoring activities, study timelines, site management, training, data discrepancy resolution, TMF/eTMF quality, safety events, protocol deviations, investigational supplies, and site visits. Serves as the primary liaison among internal teams, investigators, clients, vendors, and CROs while ensuring compliance with SOPs, regulations, Good Clinical Practice, FDA requirements, and study-specific standards.