Clinical Research Associate I

Abbott (abbottcareers2 board); United States; On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Health benefits

Tuition reimbursement

Retirement plan

Education benefits

Job summary

Abbott seeks a Clinical Research Assistant/Coordinator to ensure quality data across multiple clinical trials in Alameda, CA. You will recruit volunteers, obtain informed consent, and manage study data and files to meet regulatory standards.

Ideal candidates have a life sciences background, strong teamwork, and knowledge of CFR/ICH-GCP. You will coordinate start-up activities, monitor sites, and support regulatory submissions in a fast-paced environment.

Qualifications

• BS degree in life sciences; 0–1 year CRA/CRC/CTA experience.
• Experience with medical device studies or IVD studies preferred.
• Strong teamwork and clear communication with study staff.
• Familiarity with CFR, ICH-GCP, and regulatory affairs basics.
• Daily flexibility and adaptable to changing study needs.
• Proficient with Microsoft Office.

Responsibilities

• Run internal clinical studies, recruit participants and obtain consent; record data and maintain files.
• Coordinate studies from start to close-out and monitor progress.
• Do SQV/SIV/IMV/COV visits, write reports, track action items.
• Assist monitoring and site management; ensure compliance with protocols and regulations.
• Support study start-up activities and logistics.
• Ship study devices and supplies to sites as needed.
• Track device accountability and reconciliation.
• Help develop study forms and monitoring plans.
• Assist with CRF design and site training.
• Maintain TMF and upload to eTMF for inspection readiness.
• Review data listings for completeness; escalate issues to management.
• Communicate study status to management proactively.
• Assist with regulatory submissions reviews and audits interactions.

Skills

Teamwork

Interpersonal skills

Communication

CFR-GCP knowledge

Microsoft Suite

Education

BS in life sciences

Tools

Microsoft Word/Excel/PowerPoint

Job description

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.

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.

What You'll Work On

• Perform internal clinical studies, recruit study participants, conduct informed consent discussions with study volunteers, record study data, and maintain study files.
• Coordinate internal clinical studies from start to close-out.
• 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 escalade 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.

Required Qualifications

• BS degree in life sciences preferred with minimum 0-1 year CRA/CRC/CTA experience; or combination of some education and minimum 2 yrs experience will be considered.
• Experience in conducting 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
• Flexibility in daily activities.
• Proficient with Microsoft Suite

Preferred Qualification:

• Previous phlebotomy experience in a clinical, laboratory, hospital, or blood donation setting.
• Phlebotomy certification (e.g., CPT, PBT-ASCP, or equivalent) preferred.

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.

Diabetes

We're focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We're revolutionizing the way people monitor their glucose levels with our ne