Description
Key activities for this contract position will be:Review of TMF documentation - TMF contents are transferred from the CRO and multiple vendors to KaloBios, plus documents are submitted directly by KaloBios
Develop tools/trackers to assess the completeness and accuracy of the TMF for one completed and one ongoing Phase 2 study
Complete tracker for assigned sections of each TMF
Work with internal KaloBios team, CRO and vendors to correct any issues identified
Review of data listings and patient profiles to identify incorrect and inconsistent data. Training will be provided by the clinical study team regarding specific items to be identified either for LCRA or medical review