Maria Ali

Coordinated end-to-end clinical trial operations, ensuring compliance with study protocols and ICH-GCP requirements. Screened, consented, and monitored participants; maintained accurate EDC data, resolved data queries, and managed investigational product accountability, deviations, and SAE documentation.

Managed patient interactions, scheduling, and administrative documentation for clinical visits. Performed diagnostic tests and vital checks, including urinalysis, blood pressure, ECG, and ABI, while maintaining confidentiality and supporting EMR documentation.

Assisted pharmacists with prescription processing, including selecting appropriate products and performing accuracy checks under supervision. Maintained inventory control by monitoring stock levels and pulling expired medications at least monthly, while supporting accurate drug information for customers.

Coordinated multiple research projects, including the CanSinoBIO vaccine trial with 3,500 participants. Ensured protocol compliance with ICH-GCP and FDA regulations, resolved audit findings and data queries, and reduced average project completion time by 20% while training junior staff.

Prepared and submitted 50+ regulatory documents, including IRB submissions, amendments, and continuing reviews. Entered study data into the EDC system, supported CRF completion and informed consent documentation, and resolved discrepancies between source records and database entries to maintain data quality for audits.

Coached and mentored crew members to help them reach their potential while supervising day-to-day operations. Wrote staff evaluations and detailed supervision summaries to support performance management and goal achievement.

Master of Science in Molecular Medicine; thesis focused on structural characterization and selective inhibition of bromodomain-containing protein.

Bachelor of Science in Biochemistry; thesis studied the effect of tyrosine and tryptophan on memory of old rats.