Clinical Site Lead

🔥 0 minutes ago

🤠 Texas – Remote

🤠 Texas – Remote

💵 $61.3k - $122.7k / year

⏰ Full Time

🟠 Senior

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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Abbott

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1888

🏥 Healthcare

⚕️ Healthcare Insurance

🧬 Biotechnology

Healthcare • Healthcare Insurance • Biotechnology

Abbott is a global healthcare company committed to advancing medical technologies and improving lives around the world. It offers a broad range of leading products in diagnostics, medical devices, nutrition, and branded generic medicines. Abbott's innovations such as the FreeStyle Libre glucose monitoring systems and BinaxNOW rapid antigen tests are transforming diabetes management and COVID-19 response. Through its partnerships and initiatives, Abbott aims to foster health equity, improve access to healthcare, and address critical health challenges like malnutrition and infectious diseases. Abbott is also dedicated to sustainability and social responsibility, striving to make life-changing technologies accessible and affordable.

📋 Description

• Drive study execution and operational excellence across Abbott Cardiovascular therapies • Serve as a resource in protocol execution, product and disease-state knowledge, procedure support, procedure outcomes, clinical trial enrollment, and ICH-GCP application • Adhere to site nomination, qualification, and startup processes • Lead ongoing training and retraining of site stakeholders to ensure protocol adherence • Manage and influence site recruitment and data collection performance • Use operational metrics to minimize screen failure and attrition • Monitor site initiation, periodic, and close-out visits for regulatory, Good Clinical Practice, and accuracy compliance • Support study design, site payments, site audits, local document review, study document preparation, and submissions • Identify, develop, and maintain productive clinical sites in the Dallas and surrounding territory • Assess investigators’ interests and qualifications and identify appropriate investigators • Maintain relationships with investigators, research coordinators, regulatory personnel, and legal personnel • Provide technical support to customers and field staff • Facilitate communication between clinical sites and Abbott clinical staff • Manage site startup, qualification, initiation visits, enrollment, regulatory, and quality activities • Train facility staff on protocol requirements and technology • Develop site-specific enrollment and compliance strategies • Attend study procedures and follow-ups or ensure trained personnel attend • Collect essential documents and resolve missing data, corrections, adverse events, protocol deviations, data queries, and action items • Review investigational-site data and source documentation for accuracy and completeness • Report monitoring-visit findings and maintain complete monitoring records • Train site and Abbott staff for clinical trials and commercial launches • Collaborate with commercial partners on product education and launches • Provide technical troubleshooting and customer support • Maintain current clinical, product, competitive, scientific, and economic knowledge • Function as a local clinical and technical resource • Independently solve problems and make decisions • Communicate effectively orally and in writing

🎯 Requirements

• Associates Degree • 1 year experience • Ability to travel approximately 50% • Bachelor’s Degree or Master’s Degree in engineering, science, health science, nursing, or a related field, or equivalent or related experience in cardiology or clinical research (preferred) • 2+ years of progressively more responsible relevant clinical trial experience in the cardiovascular field (preferred) • Competency in catheterization lab and operating room protocol and procedures (preferred)

🏖️ Benefits

• Career development with an international company • Free medical coverage through the Health Investment Plan (HIP) PPO medical plan for qualifying employees • Excellent retirement savings plan with high employer contribution • Tuition reimbursement • Freedom 2 Save student debt program • FreeU education benefit • Opportunities to grow and learn • Recognition as a great place to work and a best place to work for diversity, working mothers, female executives, and scientists