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 115,000 colleagues serve people in more than 160 countries.
Meet Lingo, a new biosensing technology that provides users a window into their body. Lingo tracks key biomarkers \xe2\x80\x93 such as glucose, ketones, and lactate \xe2\x80\x93 to help people make better decisions about their health and nutrition. Biowearable technology will digitize, decentralize and democratize healthcare, enabling consumers to take control of their own health
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\xe2\x80\x99ll 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 student debt program and education benefit - an affordable and convenient path to getting a bachelor\xe2\x80\x99s 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
This Clinical Affairs Associate II position works out of our Alameda, CA, location.
Clinical Affairs Associate II will provide clinical operational support for multiple clinical studies and projects and liaise with other departments and external suppliers; support Clinical Research systems and databases; and provide logistical support to the clinical research teams. The clinical Affairs Associate is also responsible for meeting project commitments and in compliance with applicable procedures, regulations, and standards.
WHAT YOU\xe2\x80\x99LL DO
Conduct assigned clinical operation activities under the supervision of Clinical Operations Manager and in accordance with applicable regulations; GCP; and Division policies and procedures.
Prepare clinical study master file binders
Provide support and maintain Clinical Research CTMS; including user acceptance testing (UAT); setup of individual studies; management of investigator and clinical site contacts; and uploading documentation.
Trainer for CTMS and QA verification
Manage inventory and shipments for clinical instruments, equipment, supplies and specimens.
Perform denied party screening, CDAs and Clinical Research Agreements.
Conduct annual OEC review of Scientific Research and Publications
Support clinical research team with review of clinical study data.
Manage PO process including ACR\xe2\x80\x99s and Shopping Cart
Track supplies for Sunshine Act reporting
Develop process improvement initiatives
Qualifications
Bachelor degree in science or a related field is required.
Minimum of 3 years of experience in a clinical research environment or equivalent.
Strong clinical operations background
Knowledge of regulations governing medical devices.
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