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Clinical Trial Associate

Location: Irvine
Full time 8:00 AM - 5:00 PM
Contract: 2100 Hours


Responsible for but not limited to preparing, collecting, and tracking master study level documents and site non-regulatory documents, reviewing, updating, and testing clinical systems, producing reports on clinical status, trends, and metrics, facilitating communication across departments, supporting the monitoring team and study sites with relevant study information, and supporting clinical operations.


Qualifications:
•BS: science or health-related field
• Experience working on a clinical study
• Work effectively in a team/matrix environment
• Understand technical, scientific and medical information
• Handle conflict management and resolution
• Understand clinical study budgets
• Plan, organize, project manage and analyze data
• Demonstrate full competency in Microsoft Office programs.
• Understanding of Good Clinical Practices, ICH guidelines, PhRMA code, CFR Guidelines, clinical research ethics, HIPAA and patient privacy laws (plus applicable local regulations, when country-based),
• Knowledge of concepts of clinical research and drug development
• General therapeutic area education and training
• Ability to travel up to 20% of time