Senior Clinical Research Associate - AMD
Company: Abbott Laboratories
Location: Des Plaines
Posted on: April 8, 2021
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. Senior Clinical Research -
(AMD) At Abbott, we're committed to helping people live their best
possible life through the power of health. For more than 126 years,
we've brought new products and technologies to the world - in
nutrition, diagnostics, medical devices and branded generic
pharmaceuticals - that create more possibilities for more people at
all stages of life. Today, 109,000 of us are working to help people
live not just longer, but better, in the more than 150 countries we
serve. At Abbott Molecular, we realize the potential of
personalized care as the laboratory's most trusted and preferred
source for molecular diagnostic solutions. We are a division of
Abbott Laboratories, a global, diversified healthcare innovator
with a legacy of pioneering work in medical 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. Abbott Molecular Our Des Plaines, IL site has an
opportunity for a Senior Clinical Research Associate who designs,
implements, and monitors clinical studies of new and modified in
vitro diagnostic products. Ensures that the clinical studies are
conducted per established policies, procedures, regulations, and
Good Clinical Practice (GCP).Participates in the preparation of
regulatory submissions and international registration
packages.Works with minimal supervision on a single large project,
a complex project, or several smaller projects.Has established a
high degree of competence in clinical research. 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:
- Complies with all policies, established procedures, and
regulations related to clinical research.
- Actively participates as a member of the cross-functional
- Participates in assessing performance data generated by
R&D/Business Teams prior to initiation of the clinical
- 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.
- Prepares clinical 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
- Identifies and qualifies clinical investigators and clinical
- Proposes and negotiates budgets for clinical studies.
- Initiates payments to clinical sites.
- Obtains and reviews all required essential documents necessary
for study initiation.
- Collaborates with Statistical Support with the collection and
statistical analyses of clinical data.
- 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
- Conducts pre-study, initiation, interim, and closeout
monitoring site visits and completes site visit reports.
- Maintains accurate and timely sponsor/site correspondence and
- Reviews data, prepares, and presents clinical data reviews and
- Responds to audits and data queries.
- Prepares and presents project progress reports to keep
management and team informed.
- Prepares the clinical sections of regulatory submissions and
international registration packages.
- Assists Regulatory in preparing responses to regulatory
agencies' questions regarding the clinical study.
- Maintains professional, product, and market expertise via
independent reading, networking, and training.
- Functions independently in the field and interacts with all
levels of medical and scientific professionals.
- Advises and supports newly hired CRAs with department
- Suggests improvements for increased departmental
- May perform other duties as assigned. Additional Requirements:
- Successful and timely completion of clinical studies directly
impacts the ability to meet product market entry dates.
- Early identification of unsatisfactory results, operations, or
specific problems allows immediate action to be taken by
- Resolution of problems and timely data analysis is critical to
meeting the scheduled goals of the project.
- Accountable for the project scope and scheduled completion
- Works under the direction of the Clinical Project Manager.
EDUCATION AND EXPERIENCE, YOU'LL BRING Required
- B.A. or B.S. in the biological sciences, PREFERRED:Advanced
Degree, Ph. D, Master's degree is preferred, or equivalent clinical
research experience of 4 to 6 years Experience:
- Medical Technology MT(ASCP) or equivalent, or certification as
a clinical research associate (CCRA) is desirable.
- This position requires an understanding of the clinical
laboratory, assay/instrument principles involving in vitro
diagnostic product design and usage, and the scientific,
statistical, regulatory, and compliance requirements for conducting
- Minimum of 8 years relevant professional experience
- Clinical Research 2 to 3 years and Laboratory (hospital,
research, industrial) 2 to 3 years or Quality Assurance/Auditing 1
to 2 years or Customer Contact 1 to 2 years
- This position requires good oral and written communication
skills, familiarity with desktop computer office software, Travel
Requirement: up to 15- 20%
- 25 - 30% (US and/or international),
- Participation in professional activities outside of normal
business hours. 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: 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 , on Facebook at and on
Keywords: Abbott Laboratories, Des Plaines , Senior Clinical Research Associate - AMD, Healthcare , Des Plaines, Illinois
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