Clinical Study and Regulatory Assistant
Core
Facilitate operational management of non-patient facing activities to support the conduct of clinical research studies and clinical trials.
Role type
Clinical Study and Regulatory Assistant
Builds
Clinical trial data submissions, ethics documents, and regulatory compliance reports
Domain
Healthcare / Clinical Research
Required skills
Data collection and entry, Regulatory compliance, Ethics board submissions, Electronic data capture (EDC) systems, Protocol adherence, Source documentation collection
Preferred skills
Bachelor's degree in health/science, Clinical Research Graduate certificate
Technologies
Redcap, Medidata
Responsibilities
Record clinical trial data in case report forms (CRFs), Prepare submissions to Research Ethics Board (REB), Coordinate close-out phase of clinical study protocols, Liaise between site and sponsor for trial documentation, Ensure regulatory compliance for clinical research studies involving human subjects
Seniority
Junior, operational support