Clinical Research Associate I

Abbott; United States; On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Health insurance

Retirement plan

Tuition reimbursement

Education benefits

Job summary

Abbott in Alameda, California is seeking a Clinical Research Associate I to ensure quality data across multiple clinical trials. This on-site role supports monitoring visits, site management, and regulatory compliance within CFR, ICH GCP, and ISO14155 guidelines.

The CRA I will assist with start-up activities, device shipments, TMF maintenance, and data reviews, traveling up to 30-50% as needed.

Qualifications

• BS degree in life sciences or equivalent with relevant clinical research experience.
• Ability to work effectively in cross‑functional teams and communicate clearly with study sites.
• Proficient with Microsoft Office and data listing tools.

Responsibilities

• Perform study site visits (SQV/SIV/IMV/COV) and generate monitoring reports.
• Assist clinical monitoring, site management, and regulatory compliance per protocol and GCP.
• Support study start-up activities and device shipments to sites.
• Maintain TMF/upload to eTMF and assist with data listings reviews.

Skills

Clinical research experience

Teamwork

Communication skills

Microsoft Suite

Education

BS in life sciences

Tools

Microsoft Suite

Job description

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 122,000 colleagues serve people in more than 160 countries.

JOB DESCRIPTION:
Clinical Research Associate I

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You'll also have access to:

• Career development with an international company where you can grow the career you dream of.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with a high employer contribution.
• Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor's degree.
• A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

The CRA will ensure quality, accuracy, and integrity of clinical trial data throughout the full lifecycle of multiple clinical trials according to the Code of Federal Regulations, ICH GCP, and ISO14155.

This is an on-site position in Alameda, California. This is not a remote position.

What You'll Work On

• The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as assigned by management.
• Perform study site visits (SQV, SIV, IMV, COV), generate monitoring reports, and track resolution of action items.
• Assist and conduct clinical monitoring and site management activities, ensuring compliance to the Study Protocol, Good Clinical Practices (GCPs), 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 development of study-specific forms and trial-specific monitoring plans.
• Assist senior staff in study planning, designing case report forms (CRFs), and training of study sites.
• Maintain and audit Trial Master File (TMF) and upload to eTMF to ensure inspection readiness.
• Perform review of clinical data listings for completeness and accuracy; and elevate issues to the Clinical Operations Manager/Study Lead as needed.
• Proactively and effectively communicate the status of clinical studies to management.
• Participate in the interim and final reviews of study data in preparation of regulatory submissions.
• May interact with RA/QA in responding to audits and FDA inquiries.
• Perform any other duties as assigned by management.
• Must be able to travel 30-50%-, with additional travel as required.

Required Qualifications

• BS degree in life sciences preferred or equivalent with minimum one (1) year of clinical research experience, or combination of appropriate education and experience.

Preferred Qualifications

• Experience working on medical device studies and/or in-vitro diagnostics studies preferred. Pharmaceutical background may also be considered.
• Demonstrate excellence in teamwork, solid interpersonal and communication skills including building rapport with team members/peers, study site staff, and clinical management.
• Working knowledge of CFR, ICH-GCP, Clinical and Regulatory Affairs
• Proficient with Microsoft Suite
• Perform any other duties as assigned by management.

Preferred Qualifications

• Demonstrated excellence in teamwork, stellar interpersonal and communication skills including building rapport with team members, peers, and management.
• Working knowledge of GCP, Clinical and Regulatory Affairs.
• Flexibility in daily activities.
• Proficient with Microsoft Suite

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com , on Facebook at www.facebook.com/Abbott , and on Twitter @AbbottNews.

Divisional Information

Medical Devices

General Medical Devices:

Our medical devices help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks.

CRM

As a global leader in Cardiac Rhyth