Clinical Research Associate, IVD Diagnostics

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 103,000 colleagues serve people in more than 160 countries.

JOB DESCRIPTION:

ABOUT ABBOTT DIAGNOSTICS

The key to successful treatment and full recovery is often fast, accurate diagnosis. Abbott’s life-changing tests and diagnostic tools provide insights that enable smarter, faster decisions and transform the way the world is managing health.

Our pioneering technology spans the world of healthcare operations — with medical diagnostic instruments, tests, automation and informatics solutions for hospitals, reference labs, blood centers, emergency departments, physician offices and clinics.

WHAT YOU’LL DO:

The clinical research associate (CRA) designs, implements, and monitors clinical studies of new and modified in vitro-diagnostic products; he/she is responsible for implementing and maintaining the effectiveness of the quality system. Ensures that the clinical studies are designed to validate product performance claims and support the products’ intended use. Prepares clinical data reviews and data summaries. Participates in the preparation of regulatory submissions and international registration packages. In general,the CRA performs responsibilities and task under the direction of a SCRA or CPM.

Main Responsibilities:

• Implements and maintains the effectiveness of the Quality System.
• Complies with all policies,established procedures,and regulations related to clinical research.
• Actively participates as a member of the cross-functional project team.

With direction performs the following:

• Assesses data generated by R&D/Business Teams.
• Prepares design validation plans; prepares documents for clinical studies.
• Identifies and qualifies clinical investigators and clinical sites.
• Proposes and negotiates budgets for clinical studies; initiates payments to sites.
• Obtains and reviews all required essential documents necessary for study initiation.
• Reviews data,prepares and presents clinical data reviews and data summaries. Responds to audits and data queries.
• Prepares the clinical sections of regulatory submissions and international registration packages.
• Assists Regulatory in preparing responses to regulatory agencies’ questions regarding 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.
• Arranges for and assists in standard Statistical Support with the collection and statistical analyses of clinical data.
• Monitors standard clinical studies ensuring site compliance with the clinical protocol and ICH/GCP guidelines, assures subject rights, safety, and welfare is protected, ensures data integrity through completeness, accuracy, and legibility.
• Prepares and reviews product labeling and promotional materials.
• Conducts standard pre-study, initiation, interim, and close-out monitoring site visits and completes site visit reports. Initiates standard clinical studies and provides for investigator and staff training.
• Maintains accurate and timely sponsor/site correspondence and communication.
• Prepares and presents project progress reports to keep management and team informed.
• Supports publication or presentation of clinical data in professional journals or meetings.
• Maintains professional,product,and market expertise via independent reading, networking, and training.
• Implements all policies,established procedures, and regulations into daily operations as appropriate.
• Develops professional, expertise via professional and educational opportunities.
• Assumes responsibility for attending training sessions, presentations,and continuing education sessions.
• Works with assistance to prepare publications, abstracts, or presentations for professional meetings.

EDUCATION AND EXPERIENCE YOU’LL BRING

Required:

• Minimum Bachelor's degree B.S in biological sciences or medical specialty preferred.
• Minimum of 3 years clinical related experience Preferred site monitoring of investigational drug or device trials or clinical laboratory assay/instrument experience.

Preferred:

• Preferred knowledge of regulations and standards (GCP) affecting IVDs and Biologics.
• Clinical Laboratory certification (MT, ASCP or equivalent) or certification as a clinical research associate (CCRA) is desirable.  

• Accepts and completes all management-directed work assignments such as clinical assignments,travel, and other tasks.

• Demonstrates good basic writing & presentation skills.

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.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

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