Senior Clinical Research Associate

Sligo
Permanent
Full-time

23 days ago

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+353 (0) 71 9108062

Collins McNicholas

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