Clinical Research Associate I
$73,900–$116,000 year
On-siteAlameda, California, United States
Job Summary
Conduct clinical study execution and management from concept to report, including planning, implementation, and quality assurance. Perform site qualification visits, conduct investigator debarment checks, and prepare regulatory documents for study files. Manage shipment of study devices and supplies to clinical sites while maintaining communication with the device group. Maintain and audit the Trial Master File in Veeva Vault to ensure inspection readiness, and proactively communicate startup status to management. Support regulatory submissions and perform other duties as assigned by management. This role is part of Abbott's Diabetes Care division, focusing on revolutionizing glucose monitoring technology through accurate data-driven decisions.
Required Qualifications
- BS degree in life sciences
- two years of experience as a CRC/CTA or combination of appropriate education and experience
- Experience in conducting medical device studies
- pharmaceutical background
Desired Qualifications
- Demonstrated excellence in teamwork
- stellar interpersonal and communication skills including building rapport with team members, peers, and management
- Working knowledge of GCP
- Working knowledge of Clinical and Regulatory Affairs
- Flexibility in daily activities
- Proficient with Microsoft Suite
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