Job opportunity
Clinical Research Compliance Lead
The Hospital for Sick Children
Lead clinical research compliance and computerized system validation at SickKids in a hybrid, full-time two-year contract position. Apply regulatory expertise across clinical technologies.
The Clinical Research Regulatory Compliance Lead supports SickKids Clinical Research Operations and its Precision Child Health priorities. This role guides regulated clinical trials, technology implementation, validation, and standardized compliance processes. Key areas include EDC, eTMF or ISF, CTMS, eConsent, Health Canada, FDA, and ICH-GCP requirements.
Key Responsibilities:
Lead risk-based validation for GxP-impacting clinical trial technology systems
Develop requirements, validation plans, risk assessments, and test protocols
Maintain validated states through change control and periodic reviews
Develop SOPs, policies, templates, and compliance processes
Support audits, inspections, remediation, training, and regulatory inquiries
Requirements:
Bachelor's degree in a relevant health, science, research, or technology field
Minimum seven years of clinical trials experience
Knowledge of Health Canada, FDA, ICH-GCP, and TCPS 2
Experience developing SOPs, policies, and regulatory processes
Strong analytical, organizational, written, and verbal communication skills
Bring clinical trial regulations, computerized validation, and stakeholder collaboration expertise to SickKids’ compliant research operations.
#J-18808-Ljbffr
Apply on source site The Clinical Research Regulatory Compliance Lead supports SickKids Clinical Research Operations and its Precision Child Health priorities. This role guides regulated clinical trials, technology implementation, validation, and standardized compliance processes. Key areas include EDC, eTMF or ISF, CTMS, eConsent, Health Canada, FDA, and ICH-GCP requirements.
Key Responsibilities:
Lead risk-based validation for GxP-impacting clinical trial technology systems
Develop requirements, validation plans, risk assessments, and test protocols
Maintain validated states through change control and periodic reviews
Develop SOPs, policies, templates, and compliance processes
Support audits, inspections, remediation, training, and regulatory inquiries
Requirements:
Bachelor's degree in a relevant health, science, research, or technology field
Minimum seven years of clinical trials experience
Knowledge of Health Canada, FDA, ICH-GCP, and TCPS 2
Experience developing SOPs, policies, and regulatory processes
Strong analytical, organizational, written, and verbal communication skills
Bring clinical trial regulations, computerized validation, and stakeholder collaboration expertise to SickKids’ compliant research operations.
#J-18808-Ljbffr