Clinical Site Lead – Atlanta, GA Territory

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:

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.

For years, Abbott’s medical device businesses have offered technologies that are faster, more effective, and less invasive. Whether it’s glucose monitoring system, 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.

The Opportunity

The Clinical Site Lead drives study execution and operational excellence across Abbott Cardiovascular therapies (Vascular, Cardiac Rhythm Management, EP, Structural Heart, and Heart Failure) for the greater Atlanta region. This new team member is a recognized resource in protocol execution, increasing product and disease state knowledge, procedure support (as needed), procedure outcomes and early indication of trends, clinical trial enrollment, and ICH-GCP and clinical research application.

This individual will adhere to specified site nomination, qualification, and startup processes as well as lead ongoing training/retraining of all site stakeholders to ensure protocol adherence. Continuously reviews, manages, and influences all aspects of site’s recruitment and data collection performance (enrollment, discrepancy resolution, compliance, etc.). Additionally, will proactively utilize appropriate operational metrics to minimize screen failure, attrition rate, etc. and will monitor to ensure compliance with applicable regulatory requirements, Good Clinical Practice, and accuracy standards inclusive of site initiation, periodic, and close-out visits. The Clinical Site Lead may be consulted in the following areas: study design, site payments, site audits, local document review, study documents preparation, and submission to site or competent authority/ethics committee.

Note: this role is field based and requires the Clinical Site Lead to be based in the Atlanta, GA region.

What You’ll Work On

With limited direction from leadership:

Develop and maintain a productive clinical territory:

• Identify, develop, and maintain sites capable of delivering start-up goals, study participation levels and required data quality.

• Understand and assess investigators’ interests and qualifications.

• Identify appropriate investigators as defined by study-specific requirements and by the applicable regulatory code.

• Maintain open communication and relationships with key site personnel including the Principal Investigator, Research Coordinator, as well as regulatory and legal personnel.

• Provide ongoing technical support to customers and field staff.

• Facilitate communication between clinical sites and other Abbott clinical staff (e.g., operations management, study team, Site Contracts Associate), as needed.

Manage all aspects of study lifecycle to include site regulatory and quality:

• Start Up

  • Nominate, approach, and complete qualificatio