Clinical Research Associate I

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

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

This position works out remote in the Diagnostics Division.

We’re empowering smarter medical and economic decision making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people.

What You’ll Work On

• Conduct qualification, initiation, monitoring, and closeout visits at research sites in compliance with the approved protocol.
• Ensures compliance with protocol and all regulatory policies, procedures and/or guidelines during clinical studies by training/guidance of investigators/study coordinators and site staff.
• Communication with site staff including coordinators, clinical investigators, and their site staff;
• Verify adequate investigator qualifications, training and resources, including facilities, laboratories, equipment, and staff.
• Source documentation verification against case report form data, including informing the site staff of any entry errors, ensuring good documentation practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP, and applicable regulatory requirements.
• Verification that the investigator is enrolling only eligible subjects/samples.
• Ensures timely collection and review of study and regulatory documentation by obtaining, maintaining and controlling all necessary records and documentation according to procedures and regulations.
• Responsible for investigational product accountability and inventory.
• Verification and review of adverse events to confirm accurate data reporting in accordance with the protocol.
• Assess the clinical research site’s patient recruitment and retention success and offering suggestions for improvement.
• Timely completion of monitoring reports and follow-up letters, which includes providing summaries of the significant findings, deviations, deficiencies, and recommended actions to secure compliance.
• Builds and maintains relationships with sites.
• Basic knowledge in regulations for applicable geographies and types of studies (IDE, non-significant risk, feasibility, exempt, etc.).

EDUCATION AND EXPERIENCE YOU’LL BRING

Minimum Qualifications

• Bachelor's degree (life sciences or clinical research preferred) or equivalent combination of education and work experience.
• Must be detail-oriented and efficient in time management.
• Must have excellent written and verbal communication, organizational, and presentation skills.
• Must be able to work effectively with others.
• Self-directed and able to work within a fast-paced and constantly changing environment.
• Ability to multitask, prioritize, and manage t