Clinical Research Specialist

9 hours ago


Irvine, United States Insight Global Full time

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.



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