Clinical Research Associate

Abbott; Alameda (CA); On-site; USD 74,000 - 116,000; Full time

Benefits offered by this job

Free medical coverage for employeesvia

Excellent retirement savings plan

Tuition reimbursement

Education benefit - FreeU education

Job summary

Abbott in Alameda, California is seeking a Clinical Research Associate I to ensure quality, accuracy, and integrity of clinical trial data across multiple trials according to the CFR, ICH GCP, and ISO14155.

This on-site position in Alameda requires performing study visits, monitoring activities, TMF maintenance, and collaboration with study teams. Travel up to 40% may be required as projects progress.

Qualifications

• BS degree in life sciences preferred or equivalent with minimum 2 years of CRA/CRC/CTA experience.
• Experience on medical device studies and/or in-vitro diagnostics studies preferred.
• Demonstrate excellence in teamwork and 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.

Responsibilities

• 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 30-40%-, with additional travel as required.

Skills

Teamwork

Interpersonal skills

Communication

Rapport building

Education

BS degree in life sciences

Tools

Microsoft Office

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.

Clinical Research Associate I

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and 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.
• Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
• An excellent retirement savings plan with 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 around the world 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 a 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 30-40%-, with additional travel as required.

Required Qualifications

• BS degree in life sciences preferred or equivalent with minimum 2 years of as a CRA/CRC/CTA experience, or combination of appropriate education and experience.
• Experience working on medical device studies and/or in-vitro diagnostics studies preferred. Pharmaceutical background may also be considered.
• Perform any other duties as assigned by management.
• 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

Divisional Information

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 new sensing technology.

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.

The base pay for this position is $73,900.00 – $116,000.00. In specific locations, the pay range may vary from the range posted.