Clinical Research Associate I (Start Up Focus)

Clinical Research Associate I (Start Up Focus)

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 122,000 colleagues serve people in more than 160 countries.

The Opportunity

Supports clinical trial start-up activities, including investigator debarment checks, regulatory document collection, study file preparation, site qualification visits, and site selection support.

This position will be based in our Alameda, CA office.

What You'll Work On

• 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.
• Must be able to travel 30-40%

Required Qualifications

• BS degree in life sciences preferred, with 1+ 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.

Preferred Qualifications

• 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

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