Senior Clinical Site Lead

Abbott • New York, NY

3d • $78,000 - $156,000 • Remote

About The Position

Abbott is recruiting a Senior Clinical Site Lead for its field team serving 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 emerging trends, clinical trial enrollment, and ICH-GCP and clinical research practices.

The role follows site nomination, qualification, and startup processes; leads ongoing training and retraining of site stakeholders; and reviews 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 role may also advise 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 from leadership, the Senior Clinical Site Lead develops and maintains a productive clinical territory; manages study lifecycle activities, including site regulatory and quality processes; provides training and procedure coverage; collaborates with commercial partners; adapts to changing priorities; remains current in relevant clinical and product knowledge; and acts as a local clinical and technical resource. The position 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 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 startup goals, study 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, and regulatory and legal personnel.
• Provide technical support to customers and field staff, and facilitate communication between clinical sites and Abbott clinical staff as needed.
• Nominate, approach, and qualify sites; establish site and sponsor expectations; 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, assist with performance improvement, and provide timely feedback on site performance.
• 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; address 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 complete, accurate, and detailed monitoring records.
• Train site and Abbott staff for clinical trials and applicable commercial launches, and provide clinical and technical procedure support as needed.
• When appropriate, collaborate with commercial partners to educate local sales groups and customers on new and existing Abbott products.
• Meet with key customers where Abbott GCO presence can improve the customer experience; provide technical troubleshooting support.
• Adapt to shifting priorities and competing demands; remain current on relevant clinical, product, competitive, scientific, and economic developments; and maintain an area of expertise as a local resource.
• Use independent problem-solving and decision-making skills and communicate effectively orally and in writing.

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 a 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: Senior