Clinical Research Associate II – Alameda, CA (On-Site)
Job Summary
Abbott, a global leader in healthcare and medical devices, is seeking a Clinical Research Associate II to join its Diabetes Care division in Alameda, California. This on-site role will focus on managing and monitoring clinical trials from planning through execution to ensure quality, regulatory compliance, and timely delivery of study milestones. The role is ideal for experienced clinical research professionals passionate about advancing diabetes care through innovative medical technologies.
Key Responsibilities
Conduct single or multi-center medical device clinical studies.
Perform site qualification, initiation, monitoring, and close-out visits; generate reports and resolve action items.
Manage site monitoring activities ensuring adherence to protocol, GCP, ICH guidelines, and regulatory requirements.
Participate in study start-up, device shipping, site training, and study device accountability.
Support planning, CRF design, UAT, CRO selection/management, and study meetings.
Train new study investigators and oversee study-related documentation (protocols, TMF, reports).
Maintain and audit the Trial Master File for inspection readiness.
Review clinical data for completeness and escalate concerns appropriately.
Collaborate with cross-functional teams to ensure smooth study execution.
Monitor project timelines and budget compliance.
Contribute to regulatory submissions and address audit or FDA inquiries as required.
Required Skills & Qualifications
Bachelor’s degree in Life Sciences or equivalent field.
Minimum 5 years of clinical research experience.
At least 2 years of independent site monitoring experience.
Experience in medical device or in-vitro diagnostics trials preferred; pharmaceutical background considered.
Strong knowledge of clinical trial processes, CRFs, UAT, data management, and regulatory requirements.
Proficient in Microsoft Office Suite.
Excellent interpersonal, communication, and project management skills.
Ability to handle multiple priorities and changing demands.
Familiarity with GCP, ICH guidelines, and Clinical/Regulatory Affairs.
Willingness to travel 30–50%.
Perks & Benefits
Competitive salary range: $79,500 – $138,700 annually.
Comprehensive health coverage (medical, dental, vision).
Robust 401(k) plan with high employer contributions.
Tuition reimbursement and educational assistance programs.
Career growth opportunities within a global organization.
Recognized as one of the best places to work for diversity and inclusion.
About Abbott
Abbott is a world-renowned healthcare leader offering cutting-edge solutions in medical devices, diagnostics, branded generics, and nutrition. Operating in more than 160 countries, Abbott focuses on helping people lead healthier, fuller lives through advanced technology and innovation.
Work Mode: On-Site (Alameda, California)
Call to Action:
Ready to make a meaningful impact in clinical research? Apply now to join Abbott’s top-tier team driving innovation in diabetes care. Visit: Abbott Careers
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