Sania -
@sania-1e775103-f2a5-44ba-9920-9b77a832c59c
Senior CRA for oncology and CAR-T trials, ensuring ICH-GCP compliance, site execution, and patient safety.
What I'm looking for
I’m a clinical research professional with 6+ years of experience supporting Phase I–III oncology clinical trials, with a strong focus on immunotherapy and CAR■T therapy studies. I’m driven by high-quality trial execution, rigorous documentation, and clear collaboration that protects patient safety and keeps studies on track.
In my current role (Clinical Research Coordinator / CRA Support – Toronto Clinical Research Center, 2021–Present), I support oncology clinical trials by assisting CRAs with Source Data Verification (SDV), monitoring visit preparation, and regulatory documentation review. I help maintain Trial Master Files (TMF) and Investigator Site Files (ISF), and I coordinate Site Initiation Visits (SIV), Monitoring Visits (IMV), and Close■Out Visits (COV).
I work closely with cross■functional clinical teams to review CRFs, resolve clinical data queries with data management, and support key safety processes such as Serious Adverse Event (SAE) reporting. I also gain hands-on experience with Electronic Data Capture (EDC) workflows and clinical trial operations.
I’ve worked with systems including Medidata Rave, Veeva Vault, and CTMS, and I bring strong knowledge of ICH■GCP and clinical trial documentation standards. I’m especially interested in contributing to innovative CAR■T oncology trials while supporting investigators and sponsors to meet protocol and compliance requirements.
Experience
Work history, roles, and key accomplishments
Clinical Research Coordinator
Toronto Clinical Research Center
Jan 2021 - Present (5 years 3 months)
Supported Phase I–III oncology and immunotherapy trials, including CAR-T therapy studies, by assisting CRAs with source data verification, monitoring visit preparation, and regulatory documentation review. Coordinated site initiation, monitoring, and close-out visits while maintaining Trial Master Files (TMF/eTMF) and resolving clinical data queries with data management teams.
Medical Office Assistant
Healthcare Clinic
Jan 2018 - Jan 2021 (3 years)
Supported clinical study documentation and patient coordination by managing patient scheduling, informed consent documentation, and medical records. Entered clinical trial data into electronic data capture (EDC) systems and supported investigators during study visits.
Education
Degrees, certifications, and relevant coursework
Ontario College
Diploma, Medical Office Administration
Completed a Diploma in Medical Office Administration through Ontario College in Canada.
Availability
Location
Authorized to work in
Job categories
Skills
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