Teams at ProTrials Research, Inc.

Coordinates and oversees clinical trial activities from study start-up through close-out. Responsibilities include study planning, document development, site feasibility and activation, TMF quality control and inspection readiness, vendor management, resource planning, status reporting, billing and invoice tracking, regulatory compliance, and mentoring CTA team members. The role partners with sponsors, sites, project leadership, CRAs, CTAs, and cross-functional vendors to ensure timely, high-quality study execution.

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%.