Central Clinical Research Associate

About the role

Experience :5+ years of experience in Clinical research & development including clinical trial monitoring experiences. Rare diseases or observational studies, real world evidence experience will be a plus.

What you'll do

• The Central CRA serves as the primary liaison for the Principal Investigator and other site staff involved in conducting rare disease registries at the investigational…
• Involvement in the site selection process together with the Registries Team
• Assist in the collection of site documents for the Health Authority (HA)/Regulatory Authority (RA) submission and Ethics Committees (EC)/ Institutional Review Board (IRB)
• Review and check the quality of the site and study documents to submit with IRB/EC central, local, hospital committee and HA/RA
• Prepare EC cover letter and any additional materials required (if applicable)

What you need

• 5–9 yrs of experience
• Clinical research
• GCP
• Communication
• Quality control
• SOP writing
• Documentation
• Any graduate

Good to have

• Site execution
• Root cause analysis
• Technical writing