Clinical Study Regulatory Specialist I
Core
Coordinate clinical trials from protocol activation to closure, ensuring data integrity and regulatory compliance for oncology studies.
Role type
Clinical Study Regulatory Specialist
Builds
Clinical trial data packages and regulatory submissions for pharmaceutical partners and internal research
Domain
Healthcare / Oncology / Clinical Research
Required skills
Clinical trial coordination, Regulatory compliance (ICH-GCP, FDA, Health Canada), Data management (CRFs), Ethics board submissions, Informed consent drafting, Medical terminology, Quality assurance procedures
Preferred skills
Clinical Research Graduate Certificate, Oncology domain expertise
Technologies
Case Report Forms (CRFs), Hospital information systems
Responsibilities
Monitor and promote quality and integrity of clinical trial data, Compile ethics and regulatory documents, Assess and submit data to pharmaceutical companies, Interpret applicable regulations to ensure compliance, Prepare Health Canada and Research Ethics Board submissions