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 109,000 colleagues serve people in more than 160 countries.

About Abbott Diagnostics

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.

Our location in Lake Forest, IL, currently has an opportunity for a Sr Clinical Research Associate.   The senior clinical research associate (SCRA) 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 DO

• 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 include: - 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/presentations include: - Prepares and presents project progress reports to keep management and team informed.
• Obtains resolution of problems and timely data analysis is critical to meeting the scheduled goals of the project.

EDUCATION AND EXPERIENCE YOU’LL BRING

Required

• Bachelor’s Degree 
• Knowledge of regulations and standards (GCP) affecting IVDs and Biologics  
• Five years’ experience in a clinical research environment or a research laboratory with automated IVD assay/instrument experience, including data analysis and interpretation.
• Experience writing technical reports, presenting results and working with electronic document management systems (e.g. APLM, SBM and other databases)

Preferred

• B.S. in Biological Science or Medical Specialty
• Clinical Laboratory Certification MT(ASCP) or CRA (CCRA) desirable.
• Fluent in Mandarin

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:  www.abbottbenefits.com

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.

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