Join our team in Italy as an experienced CRA II or Senior CRA, where you'll monitor oncology clinical studies. This remote position offers reasonable travel and work/life balance. You'll ensure studies are conducted per protocol, SOPs, and regulations, and contribute to study setup, investigator identification, and regulatory submissions. Your voice will be heard in this smaller CRO.
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As a Clinical Research Associate II, you will monitor clinical studies at investigative sites, ensuring they're conducted and reported per protocol. You'll coordinate activities, identify investigators, and help prepare regulatory submissions with an impeccable eye for detail. You will identify risks and take responsibility for the quality of your work.
Provides overall support to study sites and clinical project teams engaged in clinical research studies, adhering to applicable protocols, SOPs, and regulatory requirements. Acts as point of contact for study sites and expected to work independently in providing support to CRA and sites. Can have increased focus on training and development of junior staff members and can act as Lead In-house CRA.
Monitor and own the progress of clinical studies at investigative sites, ensuring clinical studies are conducted, recorded, and reported per protocol, SOPs, ICH-GCP, and all applicable regulations and standards. Coordinate activities required to set up and monitor a study (i.e., identify investigators; helping prepare regulatory submissions, conducting pre-study and initiation visits, etc.).
Join the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence, as a CRA homebased in France. You will have ownership of investigator sites for assigned studies and be responsible for the successful management of the site right through to close-out. You will also plan and conduct various site visits, develop effective relationships with investigator site staff, and ensure integrity of clinical data.