Clinical Research Associate 3

🕒 il y a 22 jours

🇩🇪 Allemagne – Télétravail

💵 $98 800 - $167 200 / an

⏰ Temps Plein

🟢 Junior

🟡 Intermédiaire

🧪 Chercheur Clinique

👻 Score fantôme 0%

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Intuitive

Site WebLinkedInTous les Emplois

5001 - 10000 employés

Fondée en 1995

🏥 Santé

💼 Conseil

📦 Logistique

Healthcare • Consulting • Logistics

Intuitive est une entreprise reconnue pour ses technologies chirurgicales innovantes, notamment les systèmes chirurgicaux da Vinci, utilisés pour des interventions mini‑invasives. Forte de trois décennies de résultats éprouvés, Intuitive œuvre à faire progresser les soins de santé en proposant des parcours de formation technologique structurés et mesurables à l’intention des chirurgiens, des médecins et des équipes du bloc opératoire. Sa vision : améliorer les résultats pour les patients grâce à une prise en charge chirurgicale moins invasive. Intuitive propose également une plateforme de médias visuels dédiée à la collaboration et à l’apprentissage, le Da Vinci Hub, ainsi que la plateforme SimNow pour la formation chirurgicale. L’entreprise poursuit en continu ses efforts d’innovation afin d’explorer de nouvelles possibilités en matière de soins chirurgicaux.

Description

• Support the conduct of pre-market and post-market clinical studies in compliance with regulatory requirements • Contribute to clinical research activities and successful clinical study management • Maintain and track clinical study data, investigator qualification and selection, patient recruitment scrutiny, and study progress • Manage site start-up and activation, including study documents, IRB/EC submissions, regulatory documentation, clinical trial agreements, budgets, and monitoring plans • Amend clinical study documents and assist clinical sites with institutional review board submissions • Perform on-site and remote site qualification, initiation, interim monitoring, and close-out visits • Conduct clinical study monitoring for regulatory and protocol compliance and data accuracy • Complete source data verification in EDC systems or case report forms • Liaise with clinical trial sites on data entry, query resolution, investigational device tracking, accountability, and study oversight • Partner with data management on data cleaning • Review safety events and support safety narratives and reporting • Develop and manage the trial master file, study documentation, clinical trial management system, trip reports, site contacts, and monthly status reports • Track and process site payments and support study financial tracking • Assist the Clinical Study Manager with study scoping, study design, pre-study questionnaires, and surgeon/site selection • Support site audits and audit preparation for inspections • Collaborate with clinical study managers, CTAs, data management, biostatisticians, clinical sites, physicians, nurses, and surgeons • Review and interpret clinical literature and contribute to clinical study reports and publications

🎯 Exigences

• Previous experience implementing, helping and managing medical device trials • Significant knowledge of clinical and/or outcomes research study design • Advanced knowledge of ISO 14155, 21 CFR Parts 11, 50, 54, and 812, and other applicable regulations • Knowledge of ICH/GCP and clinical research and monitoring requirements • Clinical research/clinical trial management certification/education preferred • Prior clinical-setting experience preferred • Experience negotiating clinical research contracts and budgets • Ability to work effectively on cross-functional teams • Ability to manage multiple projects and shifting priorities • Proficiency in Microsoft Office Suite and PDF applications • Experience with electronic data capture (EDC) systems required • Experience with clinical trial management systems preferred • Experience in the medical device industry required • Experience running clinical trials focused on COPD required • Minimum 6 years of related experience with a BA/BS university degree; or minimum 4 years' experience and a Nursing degree, Master's degree, or MD/PhD with minimum 1 year's experience; or equivalent experience in a scientific field • Hospital-environment experience and experience working with nurses and surgeons preferred • Knowledge of statistics, statistical methods, and design of experiments highly preferred • Current proof of vaccination against certain diseases may be required • Preference given to qualified candidates who do not reside or plan to reside in Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, or Tennessee

🏖️ Avantages

• Base pay, incentives, benefits, and equity • Potential vaccination requirements, including COVID-19 vaccination • Equal employment opportunity and anti-discrimination protections