Clinical Research Associate

The Clinical Research Associate (CRA) participates in the preparation and execution of pre-market to post-market clinical investigations. Oversees the progress of clinical investigations by conducting site qualification, initiation, interim monitoring and close out visits to clinical sites. Monitors clinical investigations in accordance with Good Clinical Practice/ISO 14155 and procedures set forth by RQM+ and sponsors. Works closely with the Project Manager and/or Lead CRA to ensure all monitoring activities are conducted according to study requirements. Primary Responsibilities include participating in the investigator recruitment process and performing site qualification visits, evaluating the capability of the site to successfully manage and conduct clinical studies, and collaborating with the start-up department to coordinate activities with the site in preparation for the initiation of the study. The CRA also Trains site staff on the EDC system and verifies site computer system. Assists in resolving any issues to ensure compliance with site file audits in conjunction with ISS. The role is responsible for assuring adherence to Good Clinical Practice/ISO 14155, investigator integrity, and compliance with all study procedures through on-site monitoring visits. They work with sites to resolve data queries and may review clinical investigation plans, eCRFs, study manuals and other related documents, as requested by the Project Manager and/or Lead CRA. The CRA also serves as primary contact between RQM+, sponsor and investigator; coordinates all correspondence; and ensures timely transmission of clinical data with the study site and technical reporting, as requested.