HimalayasHimalayas logo
Sania -SA
Open to opportunities

Sania -

@sania-1e775103-f2a5-44ba-9920-9b77a832c59c

Senior CRA for oncology and CAR-T trials, ensuring ICH-GCP compliance, site execution, and patient safety.

Canada
Message

What I'm looking for

I’m looking for a Senior CRA role focused on CAR■T oncology trials, where I can support monitoring preparation, SDV/source review, regulatory documentation, TMF/eTMF management, and cross-functional execution under ICH■GCP with a strong patient-safety mindset.

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

TC
Current

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.

Education

Degrees, certifications, and relevant coursework

OC

Ontario College

Diploma, Medical Office Administration

Completed a Diploma in Medical Office Administration through Ontario College in Canada.

Tech stack

Software and tools used professionally

Find your dream job

Sign up now and join over 100,000 remote workers who receive personalized job alerts, curated job matches, and more for free!

Sign up
Himalayas profile for an example user named Frankie Sullivan