Clinical Research Associate I

Abbott • Alameda, CA

2d • $73,900 - $116,000 • Onsite

About The Position

This position works out of our Alameda, CA location in the Diabetes Care division where we're focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology. As the Clinical Research Associate I you will assist in the clinical execution and management of all aspects of assigned clinical studies. This includes but not limited to planning and implementation of clinical studies from concept to clinical study report per timelines and quality standards.

Requirements

• BS degree in life sciences preferred, with two years of experience as a CRC/CTA or combination of appropriate education and experience.
• Experience in conducting medical device studies preferred, pharmaceutical background may also be considered.
• Perform any other duties as assigned by management.

Nice To Haves

• Demonstrated excellence in teamwork, stellar interpersonal and communication skills including building rapport with team members, peers, and management.
• Working knowledge of GCP, Clinical and Regulatory Affairs.
• Flexibility in daily activities.
• Proficient with Microsoft Suite

Responsibilities

• Participate in study start up activities, to include but not limited to, conducting investigator debarment checks, collection of regulatory documents and preparing the study files.
• Conduct Site Qualification Visits (SQV) and reporting to ensure study staff and research site are adequate to perform ADC trials.
• Assist with shipment of study devices and supplies to clinical sites and maintain communication with the device group as required.
• Responsible for assisting senior study startup staff during site selection
• Maintain and audit Trial Master File and upload to Veeva Vault to ensure inspection readiness.
• Proactively and effectively communicate the status of clinical trial start up to management.
• Support regulatory submissions
• Perform any other duties as assigned by management.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level