Regulatory & Clinical Research Specialist

Western University; London; Vor Ort; CAD 64.000 - 91.000; Vollzeit

Zusammenfassung

Western University in Ontario seeks a Regulatory and Clinical Research Coordinator to support regulatory submissions and operationalize research studies within the APILab. The role involves preparing responses for Investigational Testing Authorizations, Clinical Trial Applications, and ethics submissions, coordinating study logistics, and training staff to ensure compliance with GCP/ICH standards.

The successful candidate will have a BSc degree (or equivalent) and at least 2 years of research

Qualifikationen

• Bachelor of Science (BSc) degree required.
• 2 years of experience supporting research studies in a clinical/research setting.
• Experience with regulatory submissions including Health Canada and local ethics submissions preferred.

Aufgaben

• Support operationalization of research studies and regulatory submissions.
• Prepare and manage submissions to regulatory bodies per GCP/ICH guidelines.
• Coordinate ethics submissions and hospital/site approvals.
• Train staff and supervise participant visits per study protocols.

Kenntnisse

Project management

Communication

Data management

Regulatory submissions

Attention to detail

GCP/ICH knowledge

Ausbildung

BSc degree or equivalent

RN/BScN or RPN experience

Tools

REDCap

eCTD format submissions

Jobbeschreibung

Western University in Ontario seeks a Regulatory and Clinical Research Coordinator to support regulatory submissions and operationalize research studies within the APILab. The role involves preparing responses for Investigational Testing Authorizations, Clinical Trial Applications, and ethics submissions, coordinating study logistics, and training staff to ensure compliance with GCP/ICH standards.

The successful candidate will have a BSc degree (or equivalent) and at least 2 years of research