Clinical Research Specialist
Apply on
ONSITE 2X A WEEK
LONG TERM ON-GOING CONTRACT
REQUIRED SKILLS AND EXPERIENCE
- 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
JOB DESCRIPTION
A medical device company located in Irvine, CA is looking for a 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.
• Risk Management: Identify and mitigate potential risks associated with clinical trials to ensure patient safety and data integrity.