Paula Schellmann

Tasks include: Coordinate and execute setup of the project in close cooperation with the PL, Attend and support coordinating the team and client meetings in cooperation with the PL, Setup and maintain study specific management tools, Set up project-related training as needed for team members in cooperation with PL, Perform quality checks, Maintain project plans, project status and other administrative reports

Tasks include: Data Entry, Data Validation, Query Integration, Archiving, Quality Control, CRF Review, Creation of Data Validation Plan, Testing of Oracle Clinical 5.0, Finalizing of Study Documents (Informed Consent, Protocol, CRF, (S)AE Report Forms)

Tasks included: Tracking, scanning, photocopying and filing of documents, uploading documents to company or sponsor specific electronic trial master file systems, general upkeep of files and administration, preparing and distribution of site files and study documents, completing transmittal forms, supporting team in Taipei locally with cleaning trial master file Insight into: preparing, conducting and follow-up of monitoring visits, working environment in Australia and Taipei

Tasks included: leading and managing the student assistant team, support of American students in any matter, registration and deregistration of students, german tutor, supervision of students during trips and travels, administrative work

Tasks included: Co-Monitoring, supporting set up of Data Entry Department and training of employees in first and second Data Entry and Oracle Clinical 4.6

Tasks included: Creation of CRF and patient information, translation of documents, data entry and validation, archiving, quality control of study reports, CRFs and analytical reports Insight into: Project Management, Regulatory Affairs, Quality Management and Control, Statistic and Data Management

Insight into: cloning, mutagenesis, cell cultivating, transfection, protein filtration and immune-blots