Senior Clinical Site Lead

Abbott • Cleveland, IL

1d • Remote

About The Position

Abbott is recruiting a Senior Clinical Site Lead for its field team covering the Cleveland, Ohio, and Buffalo, New York, surrounding territory. The role drives study execution and operational excellence across Abbott Cardiovascular therapies, including Vascular, Cardiac Rhythm Management, Electrophysiology, Structural Heart, and Heart Failure. The Senior Clinical Site Lead is a resource in 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 follows site nomination, qualification, and startup processes.

With limited direction from leadership, the role trains and retrains site stakeholders to support protocol adherence and continuously reviews, manages, and influences site recruitment and data-collection performance, including enrollment, discrepancy resolution, and compliance. The Senior Clinical Site Lead uses operational metrics to help minimize screen failures and attrition, and monitors sites for compliance with applicable regulatory requirements, Good Clinical Practice, and accuracy standards through site initiation, periodic, and close-out visits. The role 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.

This position is remote and requires approximately 50% travel. Listed physical activities include awkward, forceful, or repetitive movements; prolonged sitting; and prolonged standing.

Requirements

• Bachelor's degree in engineering, science, health science, nursing, or a related field.
• At least 2 years of progressively more responsible relevant clinical trial experience in the cardiovascular field.
• Ability to travel approximately 50% of the time.

Nice To Haves

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

Responsibilities

• Develop and maintain a productive clinical territory by identifying, developing, and maintaining sites able to meet startup goals, study participation levels, and data-quality requirements.
• Assess investigator interests and qualifications, identify investigators according to study-specific requirements and applicable regulations, and maintain relationships with investigators and other key site personnel.
• Provide ongoing technical support to customers and field staff, and facilitate communication between clinical sites and Abbott clinical staff as needed.
• Manage study lifecycle activities related to site regulatory and quality requirements, including site nomination, approach, qualification, startup, and initiation.
• 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 performance, identify challenges and successes, provide timely feedback, and help sites achieve study goals.
• Attend study procedures and follow-ups when indicated, or ensure trained personnel attend.
• Develop strategies to avoid protocol deviations, educate sites on compliance tools, provide feedback on compliance indicators, and escalate non-compliant sites according to corporate policy.
• Collect essential documents, identify and obtain missing data, make data 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.
• Promptly report monitoring-visit findings according to Abbott processes and maintain accurate, detailed, and complete monitoring-visit records.
• Train site and Abbott staff for clinical trials and applicable commercial launches, and provide clinical and technical expertise for trial procedure support as needed.
• Collaborate with commercial partners on education for local sales groups and customers about new launches and Abbott products, when appropriate.
• Meet with key customers where Abbott Global Clinical Operations presence can improve the customer experience, and provide technical troubleshooting support.
• Adapt to shifting priorities and competing demands.
• 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.
• Use independent problem-solving skills and make decisions.
• Communicate effectively in writing and orally.

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, offering an affordable and convenient path to a bachelor's degree.

What This Job Offers

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