Erik Huch

- Primary contact point between sponsor and the investigational site - Ensuring inspection readiness through compliance with the protocol, SOP, GCP, regulations and guidelines - Pre-trial-assessment, initiation, monitoring and close-out visits

- Preparation of Initiation Visits - Conduct regular on-site monitoring visits to assigned study sites at regular intervals as specified by the protocol and/or study manual - Order IMP and other supplies to ensure continued availability throughout the trial - Check of clinical / laboratory data to assist site's staff in safety and efficacy evaluations - Tracking investigator's payment - Identify adverse events and reporting them immediately if serious, unexpected or life-threatening

- Liase with Project Manager/Client with regard to Data Management - Write Data Management and Data Validation Plans - CRF Design - Design and test databases - Design and participate in testing of data entry screens - Supervise and train data entry staff - Participate in validation check programming - Contribute to system validation and development - Participate in query management - Provide medical coding - Maintain Data Management Trial Master File