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 115,000 colleagues serve people in more than 160 countries.

Job Title

Investigator Sponsored Studies I

About Abbott

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and 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.
• Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
• 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 a best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

Our location in Sylmar, CA currently has an opportunity for an Associate position for our Investigator Sponsored Studies team. In Abbott’s Heart Failure (HF) business, we’re developing solutions to diagnose, monitor and manage heart failure, allowing people to restore their health and get on with their lives.

The Investigator Sponsored Studies I 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 Investigator 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.

What You’ll Work On

• 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).
• Analyze problems, characterize issues and determine appropriate solutions.
• Provide administrative support for ISS as requested. This could include generating mail merges, faxing, copying, filing, mailings, etc.
• Resolve and/or facilitate resolution of problems including identifying causes of problems to prevent reoccurrence of problems.
• Support Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• 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.

Required Qualifications

• Clinical Data Coordinator experience or experience in a comparable or closely related clinical research environment, including direct familiarity with data management processes.
• Strong skills with MS Office applications, specifically Excel, Word, and PowerPoint are required.
• Advanced organizational skills, attentiveness to detail, ability to work under limited supervision, and ability to handle multiple projects simultaneously.
• 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.
• 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.
• Must be able to use discretion and handle sensitive/confidential information appropriately.
• Occasional overtime is a requirement of this position.

Preferred Qualifications

• Bachelor's degree (preferred) or an equivalent combination of education and work experience required.
• 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.
• Experience using Concur for payments is preferred.
• Ability to work in a highly matrixed and geographically diverse business environment.

Apply Now

* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:  www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. 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.

The base pay for this position is $53,700.00 – $107,300.00. In specific locations, the pay range may vary from the range posted.