Clinical Research Associate II

The CRA II is a seasoned, experienced professional in monitoring and site management. Responsibilities will be dependent upon the type and timing of the program to which the CRA II is assigned and typically include activities involving start-up and study implementation, on-site monitoring of clinical research studies as well as on-going site management.  Incumbents work independently as a study team member. Oversees all aspects of study site management to ensure patient safety is protected, quality of data generated by managed sites resulting in consistently low query levels and in acceptable Quality Assurance reports. Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions. Updates, tracks and maintains study specific trial management tools/systems, and status reports. Actively participates in Investigator Meetings and global clinical monitoring/project staff meetings and attends clinical training sessions according to the project specific requirements.