Clinical Study and Regulatory Specialist I
Core
Coordinate oncology and hematology clinical trials from protocol review through activation, follow-up, and closure, ensuring data integrity and regulatory compliance.
Role type
Clinical Study and Regulatory Specialist I
Builds
Clinical trial data sets and regulatory submissions for cooperative groups and pharmaceutical companies
Domain
Healthcare / Oncology / Clinical Research
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical trial coordination, regulatory file maintenance, data abstraction from source documents, query resolution, eCRF management, REB submission preparation, Health Canada submission tracking, protocol interpretation, drug dose and treatment regimen monitoring
Preferred skills
EPIC system proficiency, prior data coordinator experience, knowledge of CTCAE, ICF amendments, Clinical Research Professional certification
Technologies
eTMF, eISF, EDC systems, EPIC
Responsibilities
Maintain study regulatory submissions, organize study documentation in eTMF/eISF, enter study data via EDCs, abstract data from source documents to CRFs, resolve data queries, prepare Research Ethics Board and Health Canada submissions
Seniority
Entry-level to Junior, hands-on IC
