Website Abbott Laboratories
Abbott Laboratories
Company : Abbott Laboratories
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 114,000 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 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 position is onsite in our Alameda, CA location.
What you’ll work on
- 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 escalate 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.
- 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
- Proficient with Microsoft Suite
What We Offer
At Abbott, you can have a good job that can grow into a great career. We offer:
- Training and career development, with onboarding programs for new employees and tuition assistance
- Financial security through competitive compensation, incentives and retirement plans
- Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
- Paid time off
- 401(k) retirement savings with a generous company match
- The stability of a company with a record of strong financial performance and history of being actively involved in local communities
Learn more about our benefits that add real value to your life to help you live fully: (url removed)
Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.
Connect with us at (url removed), on Facebook at (url removed)/Abbott and on Twitter @AbbottNews and @AbbottGlobal.
The base pay for this position is $72,100.00 – $(phone number removed). In specific locations, the pay range may vary from the range posted.