Clinical Research Coordinator

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:

Clinical Research Coordinator

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

This position will work out of our Plymouth, MN location, supporting our Electrophysiology medical device division. The Clinical Research Coordinator will have an essential role supporting clinical studies on pre-market devices. In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives.

What You’ll Work On:

This position will work closely with the clinical study team and have significant interaction with research coordinators and other clinical site personnel. Furthermore, this position will provide clinical study team support to ensure compliance to study protocol, domestic and international Good Clinical Practices, applicable regulatory standards, and Abbott's Standard Operating Procedures.

Additionally:

• Serve as the primary point of contact for site-generated communications; triaging and distributing as needed to appropriate internal personnel.
• Create and maintain study files including the review and tracking of essential study site documents.
• Assist with site activation and closure activities.
• Create and manage site regulatory/subject binder(s) as well as other study related documents and ship to sites.
• Track regulatory submission and correspondence on essential study documents, including submission of progress reports to IRBs.
• Collect/organize investigator and site information and prepare/follow-up on site activation documents.
• Track study related information (site/study status, enrollment, IRB/EC status, regulatory documents).
• Assist with the development of study site communications such as newsletters and other correspondence.
• Support and track shipment of project related equipment/data between research sites, sponsor, and core labs following investigational device accountability protocols.
• Track and process invoicing
• Manage archiving of study records per Abbott’s records retention policy.
• Contribute to and assist with site audit readiness.
• Assist with scheduling study-related events (site approach/qualification visits, physician training, etc.)
• Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

Required Qualifications: 

• High school diploma / GED required.
• 3 years of experience supporting clinical studies.  
• Strong organizational skills, attentiveness to detail, ability to wor