Clinical Safety Coordinator

My client a leading global CRO are looking for a Clinical Safety Co-Ordinator to join their diverse, collaborative and inclusive Safety team. The Clinical Safety Co-Ordinator will lead & contribute to the ongoing monitoring of Safety activities for assigned projects covering diverse therapeutic areas Across multiple developmental stages. If you are looking for an exciting role in a dynamic business, please read below…

Responsibilities

• Collect, process, and track serious adverse event (SAE) reports and clinical event documents
• Generate and track study report safety narratives
• Coordinate safety surveillance activities (e.g., lab review and trend analysis);
• Generate Investigator Safety Letters; and assist in preparation of clinical safety documents
• Collect outstanding information from investigational sites in order to update and close initial SAE reports
• Coordinate basic safety surveillance activities (e.g., laboratory review) including successful communication with Medical Monitor and Clinical Safety Manager
• Draft simple study-specific safety plans (i.e., Safety Monitoring Plan, Endpoint Management Plan) and documents (i.e., SAE forms, adjudication forms) for assigned studies
• Perform data entry of cases in EudraVigilance, as applicable
• Demonstrate comprehensive knowledge of GCP Guidelines and Sponsor Standard Operating Procedures

Requirements

• Bachelor’s degree and 1-2 years of clinical safety experience
• Demonstrate comprehensive knowledge of global safety regulatory requirements
• Demonstrate fundamental knowledge of medical terminology and Good Clinical Practice (GCP) Guidelines

If you are interested, get in touch with me ASAP…

Dan Hockaday

Pharmacovigilance & Drug Safety Recruitment Consultant

Email: Dhockaday (at) barringtonjames.com

Phone: 00441293776644