Ajey N.
Specialist Quality Assurance Clinical Trial Monitor @Sunnybrook
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WORK HISTORY
Specialist Quality Assurance Clinical Trial Monitor @Sunnybrook
CA
Monitor clinical trials to ensure absolute adherence to Good Clinical Practice in accordance with ICH-GCP standards, Declaration of Helsinki, Federal Regulatory Requirements and study procedures.Currently, leading trial monitoring for TDRA (Toronto Dementia Research Alliance) and Dementia clinics which focuses on neurodegenerative diseases that result in clinical dementia, including Alzheimer’s disease, fronto-temporal degeneration, and dementia with Lewy bodies, Parkinson ’s disease dementia, and vascular cognitive impairment. Perform all types of site visits including, but not limited to, qualification visits, initiation visits, monitoring visits, motivational visits, audit support visits, and termination visits. To identify potential sites for a proposed study in conjunction with the Project Team, and conduct feasibility assessment of sites as required. To track patient recruitment by contacting investigators as specified for the study, and discuss potential study risks and opportunities with the Project Manager. To assemble files and ensure documents for the trial master file accurately reflect the progress of the study. Perform site management to ensure proper adherence to protocol, source data verification and assess CRF entries. Ensure adequacy of drug shipment and drug accountability.Liaise with the Principal Investigator, clinical operations staff and sponsor representatives as required. Organize/attend investigator meetings as required. Provide support to the Project Manager / Country Manager with ad-hoc tasks as required.
EDUCATION
LUHMS, Pakistan
Bachelor of Medicine and Bachelor of Surgery, M.B.B.S, Medicine
Kriger Research, Canada
Clinical Research and Development Program, Clinical Research
SoCRA
Certified Clinical Research Professional, Clinical Research
CJ College, Canada
Phlebotomy, Clinical Laboratory Science/Medical Technology/Technologist
Canadian Medical Council, Canada
Medical Council of Canada Evaluating Exam, Medicine
Humber College
Regulatory affairs with honors, Pharmacy Administration and Pharmacy Policy and Regulatory Affairs
Canadian Career College
Project Management (Graduate Certificate)
ABOUT AJEY N.
Tenured, dedicated, and self-motivated healthcare professional with a diverse background as an international physician and clinical researcher. Possess extensive and successful experience working in fast-paced environments, coordinating and leading in-depth clinical research studies, and ensuring consistent compliance with SOPs, ICH-GCP, FDA, and other applicable regulatory standards. Able to communicate effectively with various team members, clinicians, trial monitors, and project partners. Consistently recognized for outstanding contributions and solid reputation for resolving complex issues. Commended for organization, efficiency, priority management, and communication skills.
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