Job Opportunity:
Are you a seasoned professional looking for a challenging role in clinical research? We have an exciting opportunity for a Senior Clinical Research Associate to join our team!
Job Description:
A highly skilled and experienced Senior Clinical Research Associate is required to manage clinical trials outsourced to contract research organizations (CROs). The successful candidate will be responsible for coordinating clinical investigation activities, working closely with site staff, consultants, and teams as needed. This includes keeping study product logs and inventory up-to-date, ordering preclinical/clinical supplies when necessary, and assisting in the design and writing of protocols for preclinical & clinical studies.
The ideal candidate will have strong knowledge of quality management systems (QMS), good clinical practice (GCP), and good laboratory practice (GLP) for medical devices and clinical studies. A thorough understanding of Class III device regulations in EU, US, and globally, including ISO standards and EU Medical Device Regulation (MDR), is also essential. Experience in clinical studies for medical devices, particularly cardiovascular experience, is highly desirable.
Other key responsibilities include creating and updating clinical evaluation reports (CEPs) and certificates (CERs), supporting verification and validation studies, reviewing and qualifying new study sites, preparing and presenting site initiation and device training sessions. If you have a passion for clinical research and are looking for a stimulating challenge, we encourage you to apply for this position.
Requirements:
* Strong knowledge of QMS, GCP, and GLP for medical devices and clinical studies
* Understanding of Class III device regulations in EU, US, and globally (ISO ***** & EU MDR ********)
* 5+ years' experience in clinical studies for medical devices ideal
* Cardiovascular experience ideal
* Fluent in English (and local language if different)
* Familiar with device development from pre-clinical to commercial stage
* Knowledge of GCP in US & EU
* High attention to detail
* Aware of regulations for feasibility, pivotal, and post-market studies, and able to adjust oversight accordingly
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