Clinical Research Associate I
Location: Alameda, California, United States
Category: Research & Development
Company: Abbott
About Abbott
Abbott is a global healthcare leader committed to advancing diagnostics, medical devices, nutrition, and branded generic medicines. With a presence in more than 160 countries and over 114,000 employees, Abbott delivers technologies that support healthier lives worldwide.
Why Work at Abbott
Abbott offers the opportunity to contribute to meaningful healthcare innovation while building a long-term career. Employees benefit from:
Career development opportunities within a multinational organization
Comprehensive medical coverage for employees*
Competitive retirement savings programs
Tuition reimbursement and education assistance
A workplace consistently recognized for excellence and diversity
Strong financial stability and global impact
Position Overview
The Clinical Research Associate I (CRA I) plays a key role in ensuring the quality, accuracy, and regulatory compliance of clinical trial data across multiple studies. This is an onsite position based in Alameda, CA, responsible for supporting clinical trial execution in accordance with FDA regulations, ICH GCP guidelines, and ISO14155 standards.
Key Responsibilities
Conduct study site visits including SQV, SIV, IMV, and COV, and document findings through monitoring reports.
Support clinical monitoring, site management, and compliance with study protocols and global regulatory requirements.
Participate in site start-up activities and coordinate shipment of study devices and supplies.
Manage study device accountability and reconciliation processes.
Assist senior clinical staff with CRF design, monitoring plans, study tools, and site training.
Maintain and audit Trial Master File (TMF) and ensure timely eTMF updates.
Review clinical data for accuracy and completeness; escalate issues as needed.
Communicate study progress and risks to clinical management.
Support interim and final study data reviews for regulatory submissions.
Participate in audit preparation and responses.
Travel required: 30–50%, with potential for additional travel based on study needs.
Required Qualifications
Bachelor’s degree in Life Sciences (preferred) or equivalent experience
Minimum of 1 year of clinical research experience (industry-sponsored trials preferred)
Experience with medical device or in-vitro diagnostics studies is preferred; pharmaceutical experience may be considered
Strong understanding of CFR, ICH-GCP, and regulatory compliance
Proficiency in Microsoft Office applications
Strong teamwork, communication, and interpersonal skills
What Abbott Offers
Comprehensive training and ongoing career development
Competitive compensation and incentive programs
Medical, dental, vision, wellness, and occupational health benefits
Paid time off and strong 401(k) program with company match
Stability and long-term growth within a global organization
Compensation
Base Pay Range: $72,100 – $114,700
(Specific compensation may vary by location.)
Equal Opportunity Employer
Abbott is committed to fostering an inclusive, diverse workforce and provides equal employment opportunities for all applicants.
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Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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