A medical device company located in Irvine, CA is looking for a Sr. Clinical Research Specialist to play a critical role in the design, execution, and management of clinical research studies. The responsibilities include but are not limited to:
Study Design and Planning: Develop and design clinical research protocols, ensuring alignment with regulatory requirements and company objectives.
Project Management: Oversee the execution of clinical trials, including site selection, patient recruitment, data collection, and monitoring.
Regulatory Compliance: Ensure all clinical research activities comply with FDA regulations, ICH-GCP guidelines, and other relevant regulatory standards.
Data Analysis and Reporting: Analyze clinical trial data and prepare comprehensive reports for internal and external stakeholders.
Vendor Management: Manage relationships with clinical sites and other external partners to ensure high-quality and timely execution of clinical studies.
Risk Management: Identify and mitigate potential risks associated with clinical trials to ensure patient safety and data integrity.

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