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:
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.
Working at Abbott
At Abbott, you can do work that matters, grow, and learn, care for yourself and your 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.
- Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
- 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 the best place to work for diversity, working mothers, female executives, and scientists.
The Opportunity
Our Diagnostics business currently has an opportunity for the role of Clinical Operations Specialist for our location in Lake Forest, Illinois. The primary function of this position is to provide clinical operational support to assigned clinical studies and projects. Interact with other departments and external suppliers and provide logistical support to clinical research teams. Perform responsibilities meeting project commitments and in compliance with applicable regulations, good clinical practice (GCP) and standards.
What You’ll Work On
- Responsible for implementing and maintaining the effectiveness of the quality system.
- Conducts assigned clinical operations activities in accordance with applicable regulations; GCP; and IACC policies and procedures.
- Facilitating the execution of new CDAs and Clinical Research Agreements and amendments.
- Process and track payments related to executed Clinical Research Agreements.
- Coordinate denied party screening and maintain reports and financial disclosures.
- Coordinate orders and ship clinical supplies, instruments and specimens to sites for clinical studies.
- Support internal audit and other compliance related activities (e.g. preparation for audits, QA verification of clinical data, OEC review of Scientific Research and Publications, tracking of supplies for Sunshine Act reporting).
- Provide clinical study support to CRA’s (e.g. prepare study master file binder, route clinical records, complete study related exception reports).
- Supports clinical research team with review and monitoring of clinical study data.
- Identify need for new processes and technologies to support increase in quality, productivity and efficiency.
- Identify and participate in process improvement initiatives. May participate in a lead role for a project.
- Participate in training and educational opportunities for personal development and cross-training within the organization.
- Other responsibilities as assigned.
- Support current and new processes and procedures for the Clinical Research organization in accordance with applicable regulations; GCP; and ADD policies and procedures.
- Development and maintenance of Clinical Research procedures, templates and forms.
- Routing of clinical procedures in APLM.
- Support of new processes and technologies to support quality, productivity and efficiency of the Clinical Research organization.
EDUCATION AND EXPERIENCE YOU’LL BRING
Qualifications:
- Minimum Associates Degree and 1 year of relevant experience required.
- Bachelor's degree in biological sciences or medical specialty preferred.
- 3 years in a clinical research environment or a research laboratory with automated IVD assay/instrument experience, including data analysis strongly preferred.
- Knowledge of regulations and standards (GCP) affecting IVDs and Biologics is preferred.
- Experience with contracts and knowledge of electronic document management systems (e.g. APLM, SBM and other databases) desired.
- Demonstrates good organization, basic writing & presentation skills.
- Attention to detail strongly desired.
Learn more about our benefits that add real value to your life to help you live fully: http://www.abbottbenefits.com/pages/candidate.aspx. Follow your career aspirations to Abbott for diverse opportunities with a company that provides 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 Twitter @AbbottNews and @AbbottGlobal.
The base pay for this position is
$66,700.00 – $133,300.00
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:
Medical & Scientific Affairs
DIVISION:
CRLB Core Lab
LOCATION:
United States > Lake Forest : CP01
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
No
MEDICAL SURVEILLANCE:
No
SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)
Abbott is an Equal Opportunity Employer of
Minorities/Women/Individuals with
Disabilities/Protected Veterans.
EEO is the Law link - English:
http://webstorage.abbott.com/common/External/EEO_English.pdf
EEO is the Law link - Espanol:
http://webstorage.abbott.com/common/External/EEO_Spanish.pdf