Clinical Research Specialist

Insight Global - Irvine, CA

Full-time

Irvine, CA

Administrative and Support Services

About the position

The Clinical Research Specialist at Insight Global will play a vital role in the design, execution, and management of clinical research studies for a medical device company. This position is essential for ensuring that clinical trials are conducted in compliance with regulatory standards while also focusing on patient safety and data integrity.

Responsibilities

• Develop and design clinical research protocols, ensuring alignment with regulatory requirements and company objectives.
• Oversee the execution of clinical trials, including site selection, patient recruitment, data collection, and monitoring.
• Ensure all clinical research activities comply with FDA regulations, ICH-GCP guidelines, and other relevant regulatory standards.
• Analyze clinical trial data and prepare comprehensive reports for internal and external stakeholders.
• Identify and mitigate potential risks associated with clinical trials to ensure patient safety and data integrity.

Requirements

• 4+ years of experience in clinical research focused on medical device or pharmaceutical.
• Experience with site management.
• Experience with EDC and ETMF.
• Bachelor's Degree.