Senior Clinical Research Associate

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.

     

JOB DESCRIPTION:

Senior Clinical Research Associate

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

This position works out of our Abbott Park, IL location in the Transfusion Medicine Business. Diagnostic testing is a compass, providing information that helps in the prevention, diagnosis, and treatment of a range of health conditions.

Abbott’s life-changing tests and diagnostic tools give you accurate, timely information to better manage your health. We’re empowering smarter medical and economic decision making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people.

As the Senior Clinical Research Associate (SCRA), you’ll designs, implements, and monitors clinical studies of new and modified in vitro diagnostic products. This new team member ensures that the clinical studies are designed to validate product performance claims and support the products’ intended use as well as prepares clinical data reviews and data summaries. The SCRA will participate in the preparation of regulatory submissions and international registration packages and manage a single large project, a more complex project, or several smaller related projects. The SCRA has established a high degree of competence in clinical research and has obtained prior exposure to all aspects of a clinical study and functions at a proficient level of independence with a significant degree of autonomy in conducting clinical research.

What You’ll Work On

• Responsible for implementing and maintaining the effectiveness of the quality system.

• Actively participates as a member of the cross-functional project team. Participates in assessing performance data generated by R&D/Business Teams prior to initiation of the clinical study. Acquires a basic understanding of the principles of the assay and/or instrument and “hands-on” knowledge and skills in performing assigned assays or operating instruments.

• Serves as a consultant in a select area of expertise., Clinical monitoring responsibilities including Prepares design validation plans that meet product design goals, intended use, regulatory requirements, divisional operating procedures, and Clinical Research work instructions.

• Prepares clinical protocol, clinical brochure, case report forms, informed consents, and other required documents for clinical studies. Identifies and qualifies clinical investigators and clinical sites.

• Proposes and negotiates budgets for clinical studies.

• Acquires and reviews all required essential documents necessary for study initiation.

• Monitors clinical studies, ensuring site compliance with the clinical protocol and ICH/GCP guidelines, assures subject rights, safety, and welfare are protected, ensures data integrity through completeness, accuracy, and legibility.

• Conducts pre-study, initiation, interim, and close-out monitoring site visits and completes site visit reports.

• Responsibilities for preparing Clinical Research reports/p