Senior CRA

Barrington James is actively recruiting for a challenging role as a Clinical Research Associate (CRA II). As part of our clients in-house team, you will be responsible for site management, encompassing start-up activities both on-site and remotely across Italy. This role involves working on diverse projects from our client base, which includes small to mid-sized pharmaceutical, biotech, and medical device companies. Main Job Tasks and Responsibilities: Stay professionally updated on scientific, regulatory, and operational aspects relevant to assigned clinical projects. Assist in site selection, evaluation visits, and initiation visits to ensure a smooth start-up process for investigation sites. Conduct training for site staff on study procedures to ensure compliance with protocol and ICH-GCP standards. Perform periodic monitoring visits, reviewing Case Report Form (CRF) accuracy, completeness, and quality. Conduct source data verification and in-house review of clinical data, ensuring timely resolution of data queries. Manage investigational products and trial materials, ensuring timely and correct supply to the site. Collaborate with site staff for proper reporting of safety issues and ensure their timely resolution. Conduct study termination activities, including archiving, to ensure the smooth completion of the project. Act as the main contact for the site, ensuring close follow-up and addressing any issues promptly. Provide general support to the Clinical Research Division for quality control of clinical data. Promptly address any issues that can jeopardize the conduct of the clinical projects assigned. Guide and supervise Clinical Research Associate I (CRA I) to coach and train them on the job. Education and Experience: Education: University Degree in scientific, medical, or paramedical disciplines. Experience: Previous proven experience as a CRA, with on-site monitoring activities. Strong knowledge of clinical trial operations, GCP/ICH Guidelines, and other regulatory requirements. Specific Role Requirements and Skills: Fluent in English. Proficiency in Microsoft Office (Word, Excel, Outlook). Willingness to travel. The Benefits of Working: Meal vouchers. Mobile phone if requested by the Line Manager. Dedicated Line Manager. Monthly meetings with the line manager. Full performance and development process with end-of-year reviews. Team events and end-of-year party. Career opportunities within both our CRO departments and our TalentSource Life Sciences Unit, locally and internationally. Employee satisfaction survey for continuous improvement. The Application Process: Apply here online or reach out to Robyn McAllister at Barrington James rmcallister@barringtonjames.com #J-18808-Ljbffr