Responsibilities

The FSP CRA (Level II) will conduct remote or on-site visits to investigational sites to monitor protocol compliance, assess data quality, and ensure adherence to ICH-GCP guidelines and applicable regulations. This role involves documenting observations, escalating deficiencies, maintaining communication with investigative sites, participating in investigator meetings, and contributing to the resolution of issues and findings. Additionally, the CRA will perform physical inventory checks, manage procedures and guidelines from various sponsors, and support audit readiness while collaborating with project team members to maintain data accuracy and site processes.