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.

Senior Clinical Research Specialist

Working at Abbott

Our nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow to keeping adult bodies strong and active. Millions of people around the world count on our leading brands – including Similac®, PediaSure®, Pedialyte®, Ensure®, and Glucerna® – to help them get the nutrients they need to live their healthiest lives.

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 a high employer contribution

• Tuition reimbursement, the Freedom 2 Save (https://www.abbott.com/corpnewsroom/strategy-and-strength/tackling-student-debt-for-our-employees.html) student debt program, and FreeU (https://www.abbott.com/corpnewsroom/strategy-and-strength/college-degree-for-free-its-possible-with-freeu.html) 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 worldwide 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

This position works out of our Columbus, OH location in the Nutrition Division . In Research & Development, our ambition is providing innovative high-quality products, creating sustainable value, delivering superior user experience, and enhancing health outcomes at all stages of life.

Primary Job Function

• Manages the overall execution of the Research Services (RS) aspects of high priority and/or complex assigned clinical trials from the stages of protocol development to closeout.

• Collaborates with cross functional study team members to attain business objectives and meet established timelines.

• Responsible for ensuring that assigned projects are conducted in compliance with applicable Abbott policies and regulations.

• Represents functional area in internal and/or external audits of assigned studies.

• Participates and may lead department activities related to best practice research standards, Standard Operating Procedures (SOPs) and Good Clinical Practice (GCP).

• Represents Abbott through interactions with external stakeholders including physicians and study site personnel.

What You’ll Work On

Core Job Responsibilities:

• Reviews protocol and Case Report Forms (CRFs) during the development process and contributes to enrollment /randomization/blinding procedures.

• Enters study activity in the eTMF and Clinical Trial Management System for related system functions including document tracking, packing lists for supply and equipment shipments.

• Reviews product accountability records in electronic data capture system and works with Sites to resolve issues.

• Responsible for initiating timely payments to the sites and communicating with Clinical Planning/Finance.

• Performs randomization, product accountability and supply reconciliation for assigned studies.

• May procure and manage research supplies and equipment as needed for assigned studies.

• Obtains and manages permission of copyrighted materials utilized in assigned studies.

• Obtains translation of study related material as needed through Abbott approved life sciences translation providers.

• Assure management and control of product throughout lifecycle.

• Participates in various organizational committees and develops work flow process improvements for department procedures.

• Serves as Research Services subject matter expert for study teams and cross functional stakeholders understanding of research processes.

• Manage Investigator Sponsored Studies (ISS) throughout the lifecycle including submission, review, and approval.

• Facilitate ISS review with multiple internal SMEs, stakeholders, and Research Review Committee.

• Educate internal stakeholders on ISS process and requirements.

• Ensure ISS conducted in compliance with ISS process, Divisional and Corporate requirements

• Oversee provision of product for approved II studies.

Desired Skills:

• Excellent written and verbal communication skills.

• Strong organizational skills and attention to detail.

• Flexible, well organized, and strong communication and interpersonal skills.

• Works well under pressure, with initiative to take on unfamiliar tasks.

• Basic and some advanced computer skills (includes word processing, spreadsheets, instrumentation related to Abbott network systems and advanced technical software)

• Team oriented, with high energy and desire to achieve results. Ability to work in multidisciplinary teams and meet business goals.

• Experience with Clinical Systems including eTMF, CTMS, and Payments.

Position Accountability / Scope:

• Reports to Section Manager, Clinical Development.

Required Qualifications

• BA in health profession or scientific related field preferred.

• 5+ years’ experience in the clinical research industry preferred.

Preferred Qualifications

• Understanding of Good Clinical Practice and research industry standards preferred.

• Proficiency with clinical systems and/or experience with clinical trial management systems preferred.

• 50% Investigator Sponsored Study Management

• 50% Research Services Responsibilities

MISC:

• This is an onsite role located in Columbus, OH – this is not a remoter role/opportunity.

Apply Now (https://www.jobs.abbott/us/en)

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com (http://www.abbottbenefits.com/pages/candidate.aspx)

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.

The base pay for this position is $64,000.00 – $128,000.00. In specific locations, the pay range may vary from the range posted.

An Equal Opportunity Employer

Abbot welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

To request accommodation, please call 224-667-4913 or email corpjat@abbott.com