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 activities
* Work with site staff, consultants, and teams as needed
* Keep study product logs and inventory up to date
* Order preclinical/clinical supplies when needed
* Help design and write protocols for preclinical & clinical studies
* Do literature reviews and MAUDE searches for evaluations
* Create and update CEPs and CERs
* Support verification & validation studies
* Review and qualify new study sites
* Prepare and present site initiation & device training sessions
Knowledge, Skills and Experience Required for the Role:
* Strong knowledge of QMS, GCP & GLP for medical devices and clinical studies
* Understanding of Class III device regulations in EU, US & globally (ISO 14155 & EU MDR 2017/745)
* 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 & post-market studies, and able to adjust oversight accordingly
For a confidential discussion and more information on the role contact Courtney Russell
courtney.russell@collinsmcnicholas.ie
+353 (0) 71 9108062
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