Clinical Site Lead

Abbott • Columbus, IL

2d • Remote

About The Position

Abbott is recruiting a Clinical Site Lead for the 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 is a resource for protocol execution, product and disease-state knowledge, procedure support as needed, procedure outcomes and trend identification, clinical trial enrollment, and the application of ICH-GCP and clinical research practices. The role also supports site nomination, qualification, and start-up processes.

With limited direction from leadership, the Clinical Site Lead manages site relationships and study lifecycle activities, including site start-up, enrollment, regulatory compliance, quality, monitoring, and data collection. The role trains and retrains site stakeholders, reviews site recruitment and data performance, uses operational metrics to reduce screen failures and attrition, and monitors compliance with regulatory requirements, Good Clinical Practice, and accuracy standards. The position may also provide input on study design, site payments, audits, document review and preparation, and submissions to sites or competent authorities and ethics committees.

The role provides clinical and technical training and, when needed, procedure coverage; collaborates with commercial partners on product education; and serves as a local clinical and technical resource. The position is remote 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

• Develop and maintain a productive clinical territory by identifying and maintaining sites that can meet study start-up, participation, and data-quality goals.
• Assess investigators’ interests and qualifications and identify suitable investigators based on study requirements and applicable regulatory codes.
• Maintain relationships and open 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 sites and Abbott clinical staff.
• Manage site study lifecycle activities, including site nomination, outreach, qualification, start-up, 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 strategies to support patient enrollment, address challenges, and achieve study goals.
• Evaluate study performance and provide timely feedback to sites.
• Attend study procedures and follow-ups when indicated, or ensure trained personnel attend.
• Develop strategies to prevent protocol deviations, educate sites on compliance tools, provide feedback on compliance indicators, and escalate non-compliant sites according to corporate policy.
• Collect essential documents, obtain missing data, make data corrections, and review adverse events and protocol deviations.
• Review investigational-site data and source documentation for accuracy and completeness; facilitate resolution of data queries and action items.
• Report monitoring-visit findings promptly according to Abbott processes and maintain complete and accurate monitoring-visit records.
• Train site and Abbott staff for clinical trials and applicable commercial launches, and provide clinical and technical support for trial procedures as needed.
• Collaborate with local sales groups and educate customers on new and existing Abbott products when appropriate.
• Meet with key customers where Abbott Global Clinical Operations presence can improve the customer experience; provide technical troubleshooting support.
• Adapt to changing priorities and competing demands, solve problems independently, and make decisions.
• Stay current on clinical and Abbott product developments, competitive positioning, and published scientific and economic evidence; maintain an area of expertise and serve as a local clinical and technical resource.
• Demonstrate strong oral and written communication skills.

Benefits

• Career development opportunities with an international company.
• Employees may qualify for free medical coverage in 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, an affordable and convenient path to earning a bachelor’s degree.

What This Job Offers

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