Clinical Research Associate I

Abbott • Alameda, CA

5d • $73,900 - $116,000 • Onsite

About The Position

The Clinical Research Associate I ensures the quality, accuracy, and integrity of clinical trial data throughout the full lifecycle of multiple clinical trials, in accordance with the Code of Federal Regulations, ICH GCP, and ISO 14155. This is an on-site position in Alameda, California, and is not remote. The role includes study-site monitoring and management, study start-up support, clinical device and supply handling, trial documentation maintenance, data review, and communication with study management. Travel is required; the description specifies 30–50% travel in the responsibilities and separately lists 10% in the job details.

Requirements

• Bachelor of Science degree in life sciences or equivalent, with at least one year of clinical research experience, or an appropriate combination of education and experience.
• Working knowledge of CFR, ICH-GCP, and Clinical and Regulatory Affairs.
• Proficiency with Microsoft Suite.
• Strong teamwork, interpersonal, and communication skills, including the ability to build rapport with team members, peers, study-site staff, and clinical management.

Nice To Haves

• Experience working on medical device studies and/or in-vitro diagnostics studies; pharmaceutical experience may also be considered.
• Flexibility in daily activities.

Responsibilities

• Perform study site visits (SQV, SIV, IMV, and COV), generate monitoring reports, and track resolution of action items.
• Assist with and conduct clinical monitoring and site management activities to ensure compliance with the study protocol, GCP, ICH guidelines, federal regulations, department procedures, and other applicable regulatory requirements.
• Participate in study start-up activities.
• Assist with shipping study devices and supplies to clinical sites.
• Perform study device accountability and reconciliation.
• Assist senior staff in developing study-specific forms and trial-specific monitoring plans.
• Assist senior staff with study planning, case report form (CRF) design, and training study sites.
• Maintain and audit the Trial Master File (TMF), and upload materials to the eTMF to ensure inspection readiness.
• Review clinical data listings for completeness and accuracy, and escalate issues to the Clinical Operations Manager or Study Lead as needed.
• Communicate the status of clinical studies to management proactively and effectively.
• Participate in interim and final reviews of study data in preparation for regulatory submissions.
• Potentially interact with Regulatory Affairs and Quality Assurance in responding to audits and FDA inquiries.
• Perform other duties as assigned by management.
• Travel 30–50%, with additional travel as required.

Benefits

• Employees may qualify for free medical coverage in the Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• Retirement savings plan with a high employer contribution.
• Tuition reimbursement.
• Freedom 2 Save student debt program.
• FreeU education benefit, offering an affordable and convenient path to earning a bachelor’s degree.
• Career development opportunities with an international company.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level