Clinical Research Associate II

The CRA II oversees all aspects of study site management to ensure patient safety is protected and the quality of data generated by managed sites is consistently low. 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. If required, manages site start-up procedures including the feasibility and recruitment of potential investigators, preparation of EC/IRB submissions, collection and review of regulatory documents, review and adaptation in Patient Informed Consents, notifications to IRB, EC and regulatory authorities, translation of study-related documentation, and organization of meetings. Independently conducts all forms of site visits, including pre-study/qualification, initiation, routine monitoring, and close-out visits, in accordance with the protocol, local laws, ICH-GCP and Precision SOPs.