Clinical Site Lead

Abbott • Chicago, IL

3d • $61,300 - $122,700 • Remote

About The Position

Abbott is recruiting a Clinical Site Lead for its Indianapolis, Cincinnati, and Columbus territories. The role drives study execution and operational excellence across Abbott Cardiovascular therapies, including Vascular, Cardiac Rhythm Management, EP, Structural Heart, and Heart Failure. The Clinical Site Lead serves as a resource for protocol execution, product and disease-state knowledge, procedure support as needed, procedure outcomes and emerging trends, clinical trial enrollment, and application of ICH-GCP and clinical research practices.

The role follows site nomination, qualification, and startup processes; leads training and retraining of site stakeholders; and manages and influences site recruitment and data-collection performance. It uses operational metrics to help minimize screen failures and attrition, and monitors compliance with regulatory requirements, Good Clinical Practice, and accuracy standards through site initiation, periodic, and close-out visits. The position may also contribute to study design, site payments and audits, local document review, study-document preparation, and submissions to sites or competent authorities and ethics committees.

With limited direction, the Clinical Site Lead develops and maintains a productive clinical territory, manages site and study lifecycle activities, provides training and procedure coverage, collaborates with commercial partners, adapts to shifting priorities, and remains current in relevant clinical and product knowledge. The role is remote in the United States and requires approximately 50% travel.

Requirements

• Bachelor’s degree in engineering, science, health science, nursing, or a related field.
• At least 1 year of progressively more responsible relevant clinical trial experience in the cardiovascular field.
• Ability to travel approximately 50%.

Nice To Haves

• Competency in catheterization lab and operating room protocols and procedures.

Responsibilities

• Identify, develop, and maintain clinical sites capable of meeting study startup goals, participation levels, and data-quality requirements.
• Assess investigators’ interests and qualifications and identify investigators according to study-specific requirements and applicable regulatory codes.
• Maintain relationships and communication with investigators, research coordinators, regulatory and legal personnel, and other key site staff.
• Provide technical support to customers and field staff and facilitate communication between clinical sites and Abbott clinical staff.
• Nominate, approach, and qualify study sites; establish expectations for study execution and facilitate startup activities and site initiation visits.
• Collaborate with Abbott clinical staff on regulatory and legal requirements for study participation.
• Train facility staff on protocol requirements and technology.
• Develop site-specific enrollment strategies, assess site successes and challenges, provide timely performance feedback, and help implement techniques to achieve study goals.
• Attend study procedures and follow-ups when indicated, or ensure trained personnel attend.
• Develop strategies to avoid protocol deviations, educate sites about compliance tools, provide feedback on compliance indicators, and escalate non-compliant sites according to corporate policy.
• Collect essential documents, obtain missing data and corrections, and review adverse events and protocol deviations.
• Review site data and source documentation for accuracy and completeness; facilitate resolution of data queries and action items.
• Report monitoring-visit findings promptly and maintain accurate, detailed records of monitoring visits.
• Train site and Abbott staff for clinical trials and applicable commercial launches, and provide clinical and technical procedure support as needed.
• When appropriate, educate local sales groups about product launches and customers about Abbott products; meet key customers where Abbott GCO presence can enhance their experience and provide technical troubleshooting support.
• Adapt to shifting priorities and competing demands; remain current on clinical developments, Abbott products, competitive positioning, and published scientific and economic evidence.
• Maintain at least one area of expertise and serve as a local clinical and technical resource.
• Use independent problem-solving skills and make decisions; communicate effectively in writing and orally.

Benefits

• Career development opportunities with an international company.
• Potential eligibility for free medical coverage through the Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• Retirement savings plan with high employer contribution.
• Tuition reimbursement.
• Freedom 2 Save student debt program.
• FreeU education benefit, described as an affordable and convenient path to earning a bachelor’s degree.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level