Job Overview
We are seeking a highly skilled Clinical Research Associate to manage clinical trials outsourced to CROs. The ideal candidate will have experience in clinical studies for medical devices and a strong understanding of Class III device regulations in the EU, US, and globally.
About the Role
This is an excellent opportunity to work with site staff, consultants, and teams as needed. Key responsibilities include coordinating clinical investigation activities, keeping study product logs and inventory up to date, ordering preclinical/clinical supplies when needed, helping design and write protocols for preclinical & clinical studies, conducting literature reviews and MAUDE searches for evaluations, creating and updating CEPs and CERs, supporting verification & validation studies, reviewing and qualifying new study sites, preparing and presenting site initiation & device training sessions.
Requirements
The successful candidate will possess knowledge of QMS, GCP & GLP for medical devices and clinical studies, a high attention to detail, and awareness of regulations for feasibility, pivotal & post-market studies. Fluency in English (and local language if different) is required, as well as familiarity with device development from pre-clinical to commercial stage and knowledge of GCP in the US & EU.
Benefits
This role offers the opportunity to be part of a dynamic team and contribute to the success of our organization. The ideal candidate will be motivated by the prospect of working on exciting projects and developing their skills in a supportive environment.