Freelance Senior Clinical Research Associate and Quality Assessor/Auditor

8/1994 – offen

Responsibilities:
• Preparation of EC submission
• Identification of potential investigators
• Central point of communication for all site related issues
• Conduct of pre-study; initiation; monitoring and close-out visits, Phase I- IV-studies were conducted to a variety of standards and regulations, including European GCP guidelines and FDA Standards.

Freelance Senior Clinical Research Associate
Clinical Operations Coordinator
Lead CRA
Medical Device Clinical trial specialist
Quality assessor
Auditor

• Production of comprehensive visit reports and status reports
• Site maintenance
• Attendance at project team meetings
• Liaison with clients and investigators to ensure efficient
• Co-ordination of Clinical Monitoring Team
• Team Management in 17 Countries
• Production of status reports
• Conduction of Joint visits
• Conduction of Pre-Audits
• Attendance at project team meetings
• Quality Assurance
• Attending Project Team Meetings
• Potential Query review
• Oversee CA, LEC and EC submissions
• Audits

Klinische Arbeiten