Senior Clinical Research Associate Job Overview
As a Senior Clinical Research Associate, you will be responsible for overseeing clinical trials for innovative medical devices. This role involves coordinating study activities, managing site staff, and ensuring compliance with ISO standards and FDA regulations.
* Key Responsibilities:
o Coordinate clinical investigation activities to ensure timely completion of studies
o Work collaboratively with site staff, consultants, and teams as needed to achieve project goals
o Manage study product logs and inventory to maintain accurate records
o Order preclinical/clinical supplies when required
o Contribute to the design and writing of protocols for preclinical & clinical studies
o Perform literature reviews and MAUDE searches for evaluations
o Develop and update CEPs and CERs to ensure regulatory compliance
o Support verification & validation studies to validate products and processes
o Review and qualify new study sites to ensure suitability for clinical trials
o Prepare and present site initiation & device training sessions to educate site staff
Requirements:
* Essential Qualifications: 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
* Preferred Skills: 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