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 122,000 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.
• 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 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

We are recruiting for a Clinical Site Lead to join our field team for the Atlanta, GA and surrounding territory. The Clinical Site Lead drives study execution and operational excellence across Abbott Cardiovascular therapies (Vascular, Cardiac Rhythm Management, EP, Structural Heart, and Heart Failure). 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.

Additionally, adheres to specified site nomination, qualification, and startup processes. In this role you will lead ongoing training/retraining of all site stakeholders to ensure protocol adherence as well as continuously review, manage, and influence all aspects of site’s recruitment and data collection performance (enrollment, discrepancy resolution, compliance, etc.). The individual proactively utilizes appropriate operational metrics to minimize screen failure, attrition rate, etc. and monitors to ensure compliance with applicable regulatory requirements, Good Clinical Practice, and accuracy standards inclusive of site initiation, periodic, and close-out visits.

They may also 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.

What You’ll Work On

With limited direction from leadership:

1. 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 Principle 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.

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

• Start Up
• Nominate, approach, and complete qualification processes including establishing site/sponsor expectations for study execution.
• Facilitate all aspects of the start-up process and site initiation visits
• Understand regulatory and legal requirements for study participation at a level that allows for appropriate collaboration with Abbott clinical staff, e.g. Site CRA, Site Contract Associate.
• Train facility staff regarding protocol requirements and technology.
• Enrollment
• Develop site-specific strategies to promote appropriate patient enrollment.
• Identify site successes and challenges and assist in implementing techniques that promote study goal achievement.
• Continuously evaluate site study performance and provide timely feedback to site.
• Attend study procedures and follow-ups when indicated (or ensure trained personnel attend).
• Regulatory and Quality
• Core level Abbott certification and/or equivalent level proficiency
• Develop site-specific strategies to avoid deviations.
• Educate site on tools to facilitate compliance.
• Provide timely feedback to the sites on key compliance indicators.
• Escalate non-compliant sites according to corporate policy.
• Collect essential documents, identify and obtain missing data, data corrections, reviewing adverse events and protocol deviations.

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