Senior Clinical Site Lead

Abbott Laboratories • Lewes, DE

2d • $78,000 - $156,000

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, EP, Structural Heart, and Heart Failure. The Senior 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 application of ICH-GCP and clinical research practices.

The position manages clinical site nomination, qualification, startup, training, recruitment, data collection, and ongoing site performance. It includes monitoring for compliance with regulatory requirements, Good Clinical Practice, and accuracy standards through site initiation, periodic, and close-out visits. The role may also provide input on 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 Senior Clinical Site Lead develops productive clinical sites and manages the study lifecycle, including site regulatory and quality activities. The role provides training and procedure coverage, collaborates with commercial partners on product and customer education when appropriate, adapts to changing priorities, remains current on clinical and product developments, and serves as a local clinical and technical resource. The position requires approximately 50% travel. The stated base pay range is $78,000 to $156,000, with possible variation by location.

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%.

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, participation, and data-quality goals.
• Assess investigators’ interests and qualifications and identify appropriate investigators based on study requirements and applicable regulatory codes.
• Maintain communication with investigators, research coordinators, regulatory and legal personnel, and other key site stakeholders.
• Provide ongoing technical support to customers and field staff and facilitate communication between clinical sites and Abbott clinical staff.
• Nominate, approach, and qualify 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, identify site successes and challenges, evaluate performance, and provide timely feedback.
• 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 investigational-site data and source documentation for accuracy and completeness, and facilitate resolution of data queries and action items.
• Report monitoring-visit findings promptly according to Abbott processes and maintain complete, accurate records of monitoring visits.
• Apply clinical and technical expertise to train site and Abbott staff for clinical trials and applicable commercial launches.
• Provide clinical and technical expertise for clinical-trial procedure support as needed.
• Collaborate with local sales groups on new-product education and contribute to customer education on Abbott products when appropriate.
• Meet with key customers when Abbott GCO presence can elevate the customer experience and provide technical troubleshooting support.
• Adapt to shifting priorities and competing demands; remain current on clinical and Abbott product knowledge, 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 decision-making, and communicate effectively in writing and verbally.

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, described as an affordable and convenient path to a bachelor’s degree.
• Health and wellness benefits.

What This Job Offers

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