Clinical Research Associate I – Alameda, CA (On-Site)
Job Summary
Abbott, a global leader in healthcare and medical devices, is hiring a Clinical Research Associate I for its Diabetes Care division based in Alameda, California. This on-site role focuses on ensuring the accuracy, quality, and regulatory compliance of clinical trial data throughout various stages of diabetes-focused clinical studies. Ideal for candidates experienced in medical device or in-vitro diagnostic trials, this position offers exceptional career development and competitive compensation.
Key Responsibilities
Perform clinical monitoring site visits (SQV, SIV, IMV, COV) and generate reports.
Ensure trial conduct aligns with protocols, GCP, ICH guidelines, and federal regulations.
Participate in study start-up activities, device shipping, and site supply management.
Perform study device accountability and reconciliation.
Support development of study-specific forms and trial monitoring plans.
Assist in CRF design, site training, and study planning.
Maintain and audit the Trial Master File (TMF) and eTMF for inspection readiness.
Review clinical data listings for completeness and escalate issues as needed.
Communicate study progress effectively to clinical management.
Contribute to interim and final reviews of study data for regulatory submissions.
Interface with Regulatory/Quality Assurance teams during audits and inspections.
Travel up to 30–50% as required.
Required Skills & Qualifications
Bachelor’s degree in Life Sciences or equivalent field.
Minimum 2 years of clinical research experience (medical device/in-vitro diagnostics preferred).
Strong understanding of CFR, ICH-GCP, Clinical and Regulatory Affairs.
Proficient in Microsoft Suite (Word, Excel, PowerPoint).
Excellent teamwork, communication, and interpersonal skills.
Ability to manage site relationships and clinical trial processes.
Perks & Benefits
Competitive base salary: $72,100 – $114,700 annually.
Free medical coverage through Abbott’s HIP PPO plan.
Generous 401(k) plan with high employer contribution.
Tuition reimbursement and Freedom 2 Save student debt program.
Access to FreeU education for affordable degree completion.
International career development opportunities.
Recognized as a "Best Place to Work" for diversity and innovation.
About Abbott
Abbott is a global healthcare technology leader operating in diagnostics, medical devices, nutrition, and branded generic pharmaceuticals. With a presence in over 160 countries, Abbott delivers cutting-edge healthcare solutions to improve lives worldwide.
Work Mode: On-Site (Alameda, California)
Call to Action:
Interested in shaping the future of diabetes care? Apply now to join Abbott’s world-class clinical research team and advance your career in healthcare innovation. Visit: Abbott Careers.
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