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.
