Clinical Site Lead

Abbott • Chicago, IL

4d • $61,300 - $122,700 • Remote

About The Position

Abbott is recruiting a Clinical Site Lead for its field team covering Houston and surrounding areas, including parts of Texas and Oklahoma. 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 in 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 role supports site nomination, qualification, startup, and ongoing site performance. The Clinical Site Lead leads training and retraining of site stakeholders, promotes protocol adherence, and reviews and influences site recruitment and data collection performance. The role uses operational metrics to help minimize screening failures and attrition, and monitors regulatory compliance, Good Clinical Practice, and data accuracy through site initiation, periodic, and close-out visits. The individual may also contribute to study design, site payments, audits, local document review, study document preparation, and submissions to sites or competent authorities/ethics committees.

With limited direction from leadership, the Clinical Site Lead develops and maintains productive clinical sites; manages study lifecycle activities related to site regulation and quality; provides training and procedure coverage; collaborates with commercial partners; adapts to changing priorities; maintains current clinical and product expertise; and uses independent problem-solving and communication skills. 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, or equivalent or related experience in cardiology or clinical research.
• 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 investigator interests and qualifications and identify investigators appropriate to study-specific requirements and applicable regulatory codes.
• Maintain relationships and open communication with investigators, research coordinators, regulatory and legal personnel, and other site stakeholders.
• Provide ongoing technical support to customers and field staff and facilitate communication between clinical sites and Abbott clinical staff.
• Manage site startup, nomination, approach, qualification, study expectations, 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 patient enrollment strategies, evaluate site performance, provide feedback, and help sites address challenges and achieve study goals.
• Attend study procedures and follow-ups when indicated or ensure trained personnel attend.
• Develop site-specific strategies to prevent protocol deviations and educate sites about compliance tools and indicators.
• 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, and facilitate resolution of data queries and action items.
• Promptly report monitoring visit findings according to Abbott processes and maintain accurate, detailed records of monitoring visits.
• Train site and Abbott staff for clinical trials and applicable commercial launches, applying clinical and technical expertise.
• Provide clinical and technical support for clinical trial procedures as needed.
• Collaborate with local sales groups on new product launches and educate customers on Abbott products when appropriate.
• Meet with key customers when Abbott GCO 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 and decision-making skills and communicate effectively in writing and verbally.

Benefits

• Career development opportunities with an international company.
• Eligible 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, providing an affordable and convenient path to a bachelor’s degree.
• Health and wellness benefits.

What This Job Offers

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