The Clinical Research Associate will design, plan, and manage clinical research projects for state-of-the-art implantable medical devices, ensuring compliance with protocols, SOPs, and global regulations. This role is ideal for a self-motivated professional with strong organizational and multitasking skills, thriving in a fast-paced, entrepreneurial environment.
Key Responsibilities:
* Plan and execute pre-market and post-market clinical studies, including creating protocols, informed consent forms, and CRFs.
* Manage ethics submissions, Trial Master Files, and Investigator Site Files across multiple studies.
* Conduct site qualification, initiation, monitoring, and closure visits, preparing detailed reports on data integrity, adverse events, and protocol compliance.
* Collaborate with CROs, SMOs, and clinical sites to ensure study success and regulatory compliance.
* Track study progress, including patient screening, enrollment, and data collection, while developing clinical and regulatory reports.
* Ensure compliance with ISO 13485, ISO 14155, ICH GCP, EU MDR, and US 21 CFR 820 standards.
* Maintain study databases, perform data reviews, and provide input for regulatory submissions.
* Support QMS documentation control and cross-functional team activities.
Required Skills & Experience:
* Bachelor’s degree in Science or related field with 4+ years of medical device clinical research experience.
* Expertise in ISO 13485, ISO 14155, ICH GCP, EU MDR, and US 21 CFR 820 standards.
* Proven success managing clinical projects to deadlines with strong problem-solving skills.
* Detail-oriented, organized, and a collaborative team player with excellent communication skills.
This is a unique opportunity to join a leading medical device team and play a pivotal role in advancing innovative clinical research.
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