Shaza Mokhtar

Senior Clinical Research Coordinator @Centre universitaire de santé McGill | McGill University Health Centre

Montreal, QC, CA

Conducts subject visits in accordance with study protocols and under the direction of the PI engages with study participants both in person and via telephone. • Obtains medical history, and concomitant medications; provides instructions to participants regarding study procedures.• Coordinates day-to-day project management activities, including supply inventory to support the timely and compliant execution of clinical trials.• Manages (IP) processes, including dispensing.• Prepares and maintains comprehensive research documentation, including regulatory binders, protocol amendments, and IRB submissions.• Assists with site monitoring visits, recruitment tracking, and resolution of monitor queries; maintains consistent communication with sponsors, monitors, and internal team members.• Ensures protocol compliance through accurate documentation of screening logs, ICF records, and training records for all study staff.• Participates in subject consenting as delegated by the PI and facilitates communication with referring physicians.• Collaborates with the PI to review clinical data, labs, and adverse events in a timely manner; and manages SAE• Supports the accuracy and completeness of data through timely electronic and CRF entry and data quality checks; responds to data queries and audit requests.• Performs and documents protocol-mandated assessments such as ECG.• Maintains subject confidentiality and ensures data integrity across all aspects of study conduct.• Organizes study materials, including preparation of binders, and eligibility checklists.• Coordinates logistics for subject reimbursement and manages incoming and outgoing clinical shipments.• Participates in required training, and regular research team meetings; ensures continuous compliance with GCP and institutional policies.• Serves as a liaison to clinical monitors, and sponsors; supports all aspects of site preparedness for monitoring visits, audits, and inspections.