Clinical Research Associate I – Alameda, California, USA
Location: Alameda, California, USA
Category: Clinical Research & Development
Employment Type: Full-Time
Experience Required: Minimum 1 year in clinical research or equivalent experience
About Abbott
Abbott is a global healthcare leader dedicated to improving patient lives across diagnostics, medical devices, nutritionals, and branded generic medicines. With 114,000 colleagues across 160+ countries, Abbott offers opportunities for professional growth, career development, and meaningful contributions to healthcare innovation.
Position Overview
Abbott is seeking a Clinical Research Associate I (CRA I) to support multiple clinical trials at our Alameda, CA site. The CRA I ensures quality, accuracy, and integrity of clinical trial data throughout the study lifecycle in compliance with ICH-GCP, ISO 14155, and FDA regulations. This is an on-site role requiring 30–50% travel.
Key Responsibilities
Conduct study site visits (SQV, SIV, IMV, COV) and generate monitoring reports.
Track resolution of action items and ensure compliance with study protocols, GCP, and regulatory requirements.
Participate in study start-up activities and assist with clinical site training.
Support device accountability, shipment, and reconciliation for clinical trials.
Assist senior staff in the development of trial-specific monitoring plans and case report forms (CRFs).
Maintain and audit the Trial Master File (TMF), ensuring eTMF inspection readiness.
Review clinical data listings for accuracy and completeness and escalate issues as needed.
Collaborate with Regulatory Affairs and Quality Assurance teams for audits and FDA inquiries.
Participate in interim and final data reviews in preparation for regulatory submissions.
Perform any other duties as assigned by management.
Required Qualifications
Bachelor’s degree in Life Sciences, or equivalent combination of education and experience.
Minimum 1 year of clinical research experience, preferably in medical device or in-vitro diagnostics studies. Pharmaceutical study experience may also be considered.
Working knowledge of CFR, ICH-GCP, and clinical trial regulatory requirements.
Strong interpersonal, communication, and teamwork skills.
Proficiency in Microsoft Office Suite.
Ability to travel 30–50% as required.
Why Join Abbott?
Abbott offers a career path where your work has a direct impact on patient lives. Benefits include:
Comprehensive onboarding and career development programs.
Competitive compensation, retirement plans, and incentives.
Health and well-being programs including medical, dental, vision, and wellness support.
Paid time off, 401(k) with generous company match.
Stability of a global company recognized as a leader in healthcare innovation.
Learn more about Abbott’s benefits: www.abbottbenefits.com
Abbott is an Equal Opportunity Employer, committed to diversity, equity, and inclusion across all levels.
Base Salary Range: $72,100 – $114,700 (varies by location, experience, and internal equity)
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