Clinical Research Associate, Site Management - Italy

Job Overview Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements. Essential Functions • Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH). Ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements. • Conduct site initiation visits to ensure that sites have the necessary resources and personnel to conduct the study(ies) and report study data as required. • Perform monitoring visits at sites to ensure compliance with the study protocol, applicable regulations and guidelines, and sponsor requirements. • Ensure that sites are reporting study data accurately and in a timely manner. • Conduct close-out visits to ensure that sites have completed all study-related activities and have reported all study data as required. • Maintain accurate records of site monitoring visits, including visit reports, photographs, and other relevant documentation. • Collaborate with the sponsor and other stakeholders to resolve any issues or concerns that may arise during the conduct of the study(ies). • Ensure that sites are aware of and comply with applicable regulations and guidelines, including Good Clinical Practice (GCP) and International Conference on Harmonization (ICH). • Perform other duties as assigned by the sponsor or other stakeholders. Benefits • Opportunity to work in a dynamic and fast-paced environment. • Collaborate with a team of experienced professionals who share your passion for clinical research. • Develop your skills and knowledge through training and professional development opportunities. • Work-life balance, flexible scheduling, and remote work options available.