Ref #: 38805

Employment type: Permanent - Full-Time

Location: Clinical Trial Assistant 1/2 or senior

Posted: 04-Mar-2022


ICON/DOCS has partnered with one of the world’s leading biopharma companies on a local Monitoring FSP initiative, which has created exciting opportunities for experienced CRAs in France. Critical to the FSP implementation is the role of Clinical Research Associate. The CRA will be responsible for identifying, selecting, initiating and closing-out appropriate investigational sites for clinical studies. To monitor those sites in order to ensure that studies are carried out according to the study protocol and in accordance with related SOP, applicable regulations and the principles of ICH –GCP and with applicable regulatory requirement. The monitor has the responsibility to verify that the rights and well-being of human subjects are protected and that the reported trial data are accurate, complete, and verifiable from source documents. Home-based position travelling 30% of the time to French sites. - Key Responsibilities include, but are not limited to: • Act as the main line of communication between the sponsor and the investigator; • Verifying that all research staff, facilities and investigational products have adequate qualifications and resources and these remain adequate throughout; • Responsible for the safety and proper conduct throughout the trial; • Verifying that the investigator follows the approved protocol and all GCP procedures; • Verifying that source data/documents and other trial records are accurate, complete, and maintained; • Adverse events, concomitant medications, and inter current illnesses are reported in accordance with the protocol on the CRFs;