Ali Mehdi

Clinical Research Associate @Cheo Research Institute

Ottawa, ON, CA

Managed/monitored 14+ clinical research projects including industry sponsored clinical trials. Actively identified study-related issues and elevated them to appropriate channels. Liaised with physicians, nurses, case managers, Lab personnel, CRAs, pharmacists, and patients/family, to ensure strict protocol compliance. Led strategies for maximum patient recruitment and met targets efficiently. Identified unique patients and collaborated with sponsors to initiate trials specifically for them. Negotiated budgets for clinical trials and ran patient reimbursements. Ensured efficient management of time and expenses in support of the business. Extracted, analyzed, and submitted patient diagnostic and treatment information. Liaised extensively with IRB/REB and other regulatory bodies for initial submissions, amendments, and annual review and to ensure compliance with regulations. Coordinated specimen procurements, processing, and shipment, and handled IMP and lab inventories. Assisted in the design and maintenance of study data and clinical databases as per GCP guidelines. Ensured accuracy of patient data by verifying source data, ensuring timely reporting of AEs/SAEs, and overall management of the ISF. Developed research methodologies, prepared grants, REB/IRB applications, clinical trial applications to Health Canada, literature reviews, manuscripts, abstracts, and all other documentation associated with grant applications and research projects. Assisted with the planning, organization and implementation of locally organized conferences. Monitored eCRFs, ISFs, patient binders, and other regulatory documents to ensure compliance with ICH-GCP guidelines. Liaised with researchers, industry representatives, Health Canada stakeholders for the purpose of auditing study records.