Job Summary
Abbott is hiring a Clinical Research Associate I to join its Medical and Clinical Affairs division in Alameda, California. This on-site role is ideal for candidates with foundational clinical research experience, focusing on the integrity and accuracy of clinical trial data. The CRA will perform essential monitoring activities, site management, and support regulatory readiness across multiple clinical trials, ensuring strict adherence to ICH-GCP, CFR, and ISO14155 standards.
Key Responsibilities
Conduct study site visits (SQV, SIV, IMV, COV) and document monitoring reports.
Assist in clinical site management and monitoring to ensure protocol compliance.
Support study start-up activities, including the shipment of devices and supplies.
Perform device accountability and reconciliation checks at clinical sites.
Help develop study-specific forms and trial monitoring plans.
Participate in the design of case report forms (CRFs) and site training.
Maintain and audit the Trial Master File (TMF) for inspection readiness.
Review clinical data listings for completeness and escalate discrepancies.
Communicate study progress and site issues to Clinical Operations management.
Contribute to interim and final data reviews for regulatory submissions.
Assist in responding to regulatory audits and FDA inquiries.
Willingness to travel 30–50%, with flexibility for additional travel as needed.
Required Skills & Qualifications
Bachelor’s Degree in Life Sciences or equivalent field.
Minimum 1 year of clinical research experience or a suitable combination of education and experience.
Experience in medical device or in-vitro diagnostics studies preferred; pharmaceutical study experience considered.
Strong knowledge of CFR, ICH-GCP, Clinical and Regulatory Affairs.
Excellent interpersonal and communication skills with the ability to build rapport with sites and internal teams.
Proficient in Microsoft Office Suite (Word, Excel, Outlook, PowerPoint).
Perks & Benefits
Salary Range: $72,100 – $114,700 annually (dependent on location).
Free medical coverage via HIP PPO (after wellness assessment).
Generous retirement savings plan with high employer contribution.
Tuition reimbursement, Freedom 2 Save student debt program, FreeU education benefit.
Global career growth in a Fortune-ranked workplace recognized for diversity and innovation.
Company Description
Abbott is a world-leading healthcare innovator committed to helping people live fully through cutting-edge technologies spanning diagnostics, medical devices, nutrition, and branded generics. Abbott’s mission is to improve healthcare delivery and patient outcomes worldwide.
Work Mode: On-site – Alameda, CA
Call to Action
Ready to grow your career in clinical research with a global healthcare leader? Apply now to become a part of Abbott’s dynamic Clinical Research team and make a lasting impact in healthcare innovation..
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