Teams at NAMSA

Manages clinical research studies involving site monitoring, human subject protection, GCP and regulatory compliance. Coordinates site qualification, initiation, interim and close-out visits; oversees study documentation, metrics, training, audits, budgets, safety activities and regulatory submissions. Supports protocol development, data management, core laboratory operations, literature reviews and trial registration. Mentors CRAs and communicates study performance, risks and progress to investigators, clients and internal teams.

Manages clinical studies from site selection and regulatory submissions through enrollment, monitoring, data quality review, and close-out. Develops study materials, tracking tools, project plans, and clinical study reports; coordinates cross-functional teams, investigators, sponsors, core laboratories, and safety committees. Ensures GCP, protocol, SOP, regulatory, audit, and Trial Master File compliance. Supports clinical audits, inspections, site issue resolution, and study-system implementation. Travel is typically 20–30%.

Manage and improve processes for Individual Case Safety Reports (ICSRs), CECs, and DMCs; intake, analyze, code (MedDRA), and enter adverse event data into EDC and safety databases; write narratives and aggregate reports; support SOPs, QA, and regulatory submissions; coordinate CEC/DMC activities; mentor junior staff; and contribute to system design, metrics tracking, and study-specific safety documentation.