InHouse Clinical Research Associate, Italy

Your responsibilities will include: Work independently and proactively to coordinate all necessary activities for site regulatory submissions and essential document collection for allocated clinical research sites. Manage multiple sets of essential regulatory documents across several studies and division portfolios. Develop and foster clinical research site relationships to become a subject matter expert in the site start up regulatory process across multiple studies. Manage to achieve target IRB/EC timelines by assisting clinical research sites with the application submission process and approval tracking. Manage and problem solve site start up challenges that arise to mitigate impact to service level agreement and study goals. Develop, prepare, complete and track required regulatory, ICF and legal documentation. Support internal quality audits, regulatory inspections, as applicable. Provide updates to leadership on site start up activities, investigator readiness, regulatory submission, approval status, etc. Ensure compliance with appropriate regulatory requirements (ICH/GCP, MDR, GDPR, etc.) and internal SOPs/WI, policies & procedures. Bachelor's Degree, or an equivalent combination of experience and education. Background with Submitting Studies to the Ethics Committee in Italy Fluency (written and spoken) in English, Italian a 3rd language will be a plus and highly considered. Ability to multi-task: support several studies and/or personnel simultaneously, work in a very fast-paced environment. Ability to work in a team environment and possess clear, concise communication & presentation skills - written and verbal. Must be comfortable interacting with clinical research site personnel via phone and email. Experience working with clinical trial management systems (e.g., Siebel CTMS, Veeva) and clinical document control systems / eTMF. Research Coordinator or In-House Clinical Research Associate / Clinical Research Associate (monitor)/Study Start up specialist experience.