Clinical Site Lead

🕒 il y a 12 jours

🤠 Texas – Distant

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💵 $61 300 - $122 700 / an

⏰ Temps Plein

🟠 Senior

🦅 Parrain de Visa H1B

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👻 Score fantôme 0%

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🗣️🇺🇸🇬🇧 Anglais requis

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Logo of Abbott

Abbott

10 000+ employés

Fondée en 1888

🏥 Santé

⚕️ Assurance santé

🧬 Biotechnologie

Healthcare • Healthcare Insurance • Biotechnology

Abbott est une entreprise mondiale de soins de santé engagée dans l'avancement des technologies médicales et l'amélioration des vies à travers le monde. Elle propose une large gamme de produits de premier plan dans le domaine du diagnostic, des dispositifs médicaux, de la nutrition et des médicaments génériques de marque. Les innovations d'Abbott, telles que les systèmes de surveillance de la glycémie FreeStyle Libre et les tests antigéniques rapides BinaxNOW, transforment la gestion du diabète et la réponse à la COVID-19. Grâce à ses partenariats et initiatives, Abbott vise à promouvoir l'équité en matière de santé, à améliorer l'accès aux soins et à relever des défis sanitaires critiques tels que la malnutrition et les maladies infectieuses. Abbott est également dévouée au développement durable et à la responsabilité sociale, s'efforçant de rendre les technologies qui changent la vie accessibles et abordables.

Description

• Drive study execution and operational excellence across Abbott Cardiovascular therapies • Support protocol execution, product and disease-state knowledge, procedure support, procedure outcomes, trend identification, 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 site recruitment and data collection performance, including enrollment, discrepancy resolution, and compliance • Use operational metrics to minimize screen failure and attrition • Monitor compliance with regulatory requirements, Good Clinical Practice, and accuracy standards through site initiation, periodic, and close-out visits • Develop and maintain a productive Dallas-area clinical territory and qualified clinical sites • Assess investigators and identify appropriate investigators according to study-specific and regulatory requirements • Maintain relationships with principal 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 study startup, enrollment, regulatory, and quality activities • Nominate and qualify sites, establish execution expectations, and facilitate site initiation visits • Train facility staff on protocol requirements and technology • Develop site-specific enrollment and deviation-avoidance strategies • Evaluate site performance and provide feedback • Attend study procedures and follow-ups or ensure trained personnel attend • Collect essential documents, obtain missing data, review adverse events and protocol deviations • Review source documentation and investigational-site data for accuracy and completeness • Resolve data queries and action items • 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 customer support • Provide technical troubleshooting and clinical expertise • Adapt to shifting priorities and competing demands • Maintain an area of clinical and technical expertise

🎯 Exigences

• Associates Degree • 1 year experience • Preferred: 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: Ability to travel approximately 50% • Core level Abbott certification and/or equivalent level proficiency • Excellent oral and written communication skills • Independent problem-solving skills and ability to make decisions • Ability to remain current on clinical and Abbott product knowledge, competitive positioning, and published scientific and economic evidence

🏖️ Avantages

• Career development with an international company • Free medical coverage eligibility through the Health Investment Plan (HIP) PPO medical plan • Retirement savings plan with high employer contribution • Tuition reimbursement • Freedom 2 Save student debt program • FreeU education benefit • Employee diversity and workplace recognition programs

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