Clinical Research Associate I – Start Up Focus

About Abbott

Abbott is a leading global healthcare company dedicated to helping individuals live healthier lives at every stage. With a broad portfolio encompassing diagnostics, medical devices, nutritionals, and branded generics, Abbott operates across more than 160 countries with over 115,000 colleagues.

Position Overview

The Clinical Research Associate I role focuses on clinical trial start-up activities in the medical device sector. The position is based in Alameda, CA and emphasizes supporting new study initiations, including document collection, site qualification, and regulatory compliance to ensure efficient trial launches.

Key Responsibilities

• Coordinate and conduct clinical trial start-up tasks such as investigator eligibility verification, compiling regulatory documents, and preparing study files.
• Execute Site Qualification Visits (SQV) and assess site readiness and staff competence for clinical trials.
• Assist with logistics of sending study devices and materials to trial sites, maintaining close communication with device teams.
• Support senior personnel in site selection processes.
• Maintain and audit Trial Master Files, uploading documentation to Veeva Vault to ensure inspection preparedness.
• Provide proactive updates on start-up progress to management.
• Contribute to regulatory submission processes.
• Fulfill additional duties as assigned by management.
• Travel up to 30-40% as required for site visits and related activities.

Required Qualifications

• Bachelor's degree in life sciences preferred, or equivalent education and experience with a minimum of two years working as a Clinical Research Coordinator (CRC) or Clinical Trial Assistant (CTA).
• Experience with medical device clinical studies preferred; pharmaceutical experience may also be considered.

Preferred Qualifications

• Strong teamwork skills with excellent interpersonal and communication abilities to build rapport at all organizational levels.
• Working knowledge of Good Clinical Practice (GCP), clinical trial, and regulatory affairs processes.
• Adaptability and flexibility to manage varying daily responsibilities.
• Proficiency in Microsoft Office suite.

Additional Information

• This position offers career growth within an internationally recognized company that values diversity, inclusion, and employees' well-being.
• Benefits include free medical coverage eligibility under Abbott’s Health Investment Plan PPO, comprehensive retirement plans with substantial employer contributions, tuition reimbursement and educational support programs, and recognition as a top global employer.
• The salary range for this role is $73,900 to $116,000 annually, with variances depending on location.

About Abbott’s Divisions

Abbott consists of multiple business units including Medical Devices, Diagnostics, and Nutrition. Each division strives to improve health outcomes, such as the Medical Devices segment working on cardiac rhythm management, diabetes care, vascular solutions, neuromodulation therapies, structural heart disease devices, electrophysiology, and heart failure management.

The diagnostics sector powers smarter medical decisions globally, while the nutrition business develops science-based products supporting all life stages.

Equal Opportunity Statement

Abbott is an Equal Opportunity Employer committed to workplace diversity and inclusion, encouraging applicants from all backgrounds.