An excellent opportunity for a Senior CRA to join a startup Medical Devices company to manage clinical trials outsourced to CRO's.
The Senior CRA manages clinical study activities as part of the clinical team, supporting the development of innovative medical devices in line with ISO standards, FDA regulations, EU MDR, the company's Quality Management System, and other applicable requirements.Overview of your responsibilities (full job description available on request):Coordinate clinical investigation activitiesWork with site staff, consultants, and teams as neededKeep study product logs and inventory up to dateOrder preclinical/clinical supplies when neededHelp design and write protocols for preclinical & clinical studiesDo literature reviews and MAUDE searches for evaluationsCreate and update CEPs and CERsSupport verification & validation studiesReview and qualify new study sitesPrepare and present site initiation & device training sessionsKnowledge, Skills and Experience Required for the Role:Strong knowledge of QMS, GCP & GLP for medical devices and clinical studiesUnderstanding of Class III device regulations in EU, US & globally (ISO 14155 & EU MDR 2017/745)5+ years' experience in clinical studies for medical devices idealCardiovascular experience idealFluent in English (and local language if different)Familiar with device development from pre-clinical to commercial stageKnowledge of GCP in US & EUHigh attention to detailAware of regulations for feasibility, pivotal & post-market studies, and able to adjust oversight accordingly