Lead CRA / Study Manager Freelance

10/2004 – 9/2017

• Vendor Management
• Registration of the trial in EudraCT
• Managing site contracts and investigator payments
• Organizing of kick-off meetings and investigator meetings
• Conduct of kick-off meetings and investigator meetings
• Planning, conduct and FU of regular TCs with sponsor
• Conduct of regular safety TCs with medical monitor(s) and investigators
• Preparation and conduct of data management data/query reconciliation meetings
• Creation of weekly tracking reports and monthly reports for sponsor
• Site feasibility analysis, site selection and all types of site montoring visits (SIV to COV)
• Application for subject trial insurance
• Control of periodic safety reports to authorities
• Control of documentation for ethics committee submissions including amendments
• Review of protocols and PICs and other essential documents
• Performing site feasibility assessments with LCRA
• Control of documentation for regulatory authority submissions including amendments
• Control of CTAF, Substantial Amendment Notification Form
• Control of regular safety updates and reports to EC
• Tracking trial supplies i.e lab kits, leased equipment etc.
• Preparing for EC audits and inspections by regulatory authorities
• Working with clinical trial management systems (IMPACT)
• Working with Medidata Rave, IBM Clinical Development
• Authoring SOPs

Medizinforschung, Forschung & Entwicklung (allg.), Pharmaforschung, Klinische Studie, Klinische Monitor (CRA)