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
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.
Medical Devices
For years, Abbott’s medical device businesses have offered technologies that are faster, more effective, and less invasive. Whether it’s glucose monitoring systems, innovative therapies for treating heart disease, or products that help people with chronic pain or movement disorders, our medical device technologies are designed to help people live their lives better and healthier. Every day, our technologies help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks.
Our location in Sylmar, CA currently has an opportunity for a Coordinator for Investigator Sponsored Studies.
WHAT YOU’LL DO
The Investigator Sponsored Studies Coordinator is an important contributor to our team. In this role, you will provide Investigator Sponsored Study (ISS) support including entering, reviewing, verifying, modifying and organizing incoming/outgoing documentation using web-based software.
The Coordinator identifies potential issues that could affect the quality of documentation and processes and recommends appropriate solutions. This person will take initiative and assume responsibility to help improve the efficiency and quality of the ISS process, reach out to customers for clarification on missing data, and ensure that the quality of services meets internal and external customer requirements.
When appropriate, you will also give guidance to functional partners in determining solutions to ISS process issues and/or problems. You can expect to be cross-trained on all ISS processes supported by Medical Device Medical Affairs. On a daily basis, you will be accountable for the following:
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Process incoming forms accurately and according to departmental processes. This includes the accurate and timely entry of forms into a database, the quality review and verification of forms already entered, the identification and correction of errors and the organization of clinical documentation (forms, correspondence and other supporting clinical documentation).
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Analyze problems, characterize issues and determine appropriate solutions.
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Provide administrative support for ISS as requested. This could include generating mail merges, faxing, copying, filing, mailings, etc.
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Resolve and/or facilitate resolution of problems including identifying causes of problems to prevent reoccurrence of problems.
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Support Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
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Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
EDUCATION AND EXPERIENCE YOU’LL BRING
Required
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Bachelor’s degree (preferred) or an equivalent combination of education and work experience required.
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Clinical Data Coordinator experience or experience in a comparable or closely related clinical research environment, including direct familiarity with data management processes.
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Strong skills with MS Office applications, specifically Excel, Word, and PowerPoint are required.
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Advanced organizational skills, attentiveness to detail, ability to work under limited supervision, and ability to handle multiple projects simultaneously.
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Ability to understand and comply with applicable U.S. Food and Drug Administration (FDA) regulations and Company operating procedures, processes, policies and rules is essential.
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Must have comprehensive interpersonal skills, including the ability to listen, resolve relatively complex problems, and deal with unresolved issues, delays and unexpected events, while effectively communicating and maintaining rapport with field clinical engineers and study coordinators.
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Must be able to use discretion and handle sensitive/confidential information appropriately.
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Occasional overtime is a requirement of this position.
Preferred
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Experience with FDA, Good Manufacturing Practices (GMP), and Good Clinical Practices (GCP) regulations as they apply to Clinical Data Management and to the clinical trial process.
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Experience using Concur for payments is preferred.
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Ability to work in a highly matrixed and geographically diverse business environment.
WHAT WE OFFER
At Abbott, you can have a good job that can grow into a great career. We offer:
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Training and career development, with onboarding programs for new employees and tuition assistance
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Financial security through competitive compensation, incentives and retirement plans
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Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
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Paid time off
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401(k) retirement savings with a generous company match
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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: http://www.abbottbenefits.com/pages/candidate.aspx
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.