Megha Parashar

Clinical research professional with 2+ years at Toronto General Hospital (UHN). Handled REB/Health Canada submissions, TMF/CTMS documentation, and vendor budgets, invoicing, and contract negotiation across 10+ cardiology trials. Currently supporting an investigator-initiated study. M.Sc. in Biomedical Engineering (Life Sciences-related field).

Clinical Research Analyst - Toronto General Hospital, University Health Network (UHN) - Toronto, ON

(2025-01)

Sponsors: AstraZeneca, Eli Lilly, Alnylam, QanatPharma AG, Ionis Pharmaceuticals

• Reviewed essential and regulatory documents for ICH-GCP compliance across 10+ cardiology trials; maintain 100% audit readiness.
• Prepared and submitted REB/Health Canada packages, amendments, safety reports, and continuing reviews; distributed and tracked SUSARs to investigational sites.
• Managed TMF/eTMF and CTMS set-up, maintenance, and archival across 10+ studies.
• Coordinated vendor budgets, invoicing, and contract negotiation for site-level trial activities.
• Supported site monitoring visits and have experience using IWRS.
• Shipped and tracked documents, site binders, manuals, and study supplies; coordinated investigator and sponsor meetings.
• Developed study newsletters and maintained Investigator Site File (ISF) logs.
• Coordinated site initiation visit (SIV) logistics and protocol training with sponsors, CROs, and internal teams to support study start-up timelines.
• Conducted internal QC audits and supported SOP reviews as a Quality Assurance team member; currently supporting an investigator-initiated study.

Clinical Research Study Assistant - Toronto General Hospital, University Health Network (UHN) - Toronto, ON

(2024-01 - 2024-12)

• Performed data verification (QC) of clinical data entered in eCRFs against source documents and patient Case Report Forms (CRFs).
• Supported preparation and QC review of REB submission packages and Informed Consent Form (ICF) revisions for new cardiology trials, contributing to timely regulatory and ethics approvals.
• Centralized and maintained essential regulatory documents in support of continuous inspection readiness, reducing document retrieval time during sponsor monitoring visits and audits.
• Coordinated 30+ participant visits, supporting recruitment, eligibility screening, and informed consent.

Research Trainee - Toronto General Hospital, University Health Network (UHN) - Toronto, ON

(2023-04 - 2023-12)

• Audited 50+ patient and regulatory binders for ICH-GCP compliance ahead of monitoring visits.
• Trained staff on CAPCR (UHN REB platform) for compliant ethics submissions.
• Supported coordinators and investigators with study administration and documentation.

Post-Graduate Diploma - Clinical Research - Seneca College (2023)

Master of Science (M.Sc.) - Biomedical Engineering - University of Toronto (2019 - 2020)