Senior Clinical Research Associate

đŸ”„ 21 hours ago

🇭đŸ‡ș Hungary – Remote

⏰ Full Time

🟠 Senior

đŸ§Ș Clinical Research

đŸ‘» Ghost score 10%

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Logo of AbbVie

AbbVie

10,000+ employees

Founded 2013

đŸ„ Healthcare

đŸ’Œ Consulting

🏭 Manufacturing

Healthcare ‱ Consulting ‱ Manufacturing

AbbVie is a global pharmaceutical company that discovers and delivers innovative medicines and solutions to enhance lives. With a focus on addressing the world's toughest health challenges, AbbVie operates in over 175 countries, providing a wide range of products across areas like immunology, oncology, neuroscience, and aesthetics. Committed to scientific innovation, AbbVie invests heavily in research and development, aiming to produce first-in-class medicines. The company also emphasizes workplace diversity, sustainability, and patient support initiatives, ensuring positive impact for both its patients and the broader community.

📋 Description

‱ Execute protocol-level SMM deliverables for assigned sites and studies across start-up, execution, and close-out ‱ Conduct monitoring visits, site evaluations, site selection and activation, monitoring close-out, and visit reporting ‱ Anticipate and resolve site issues affecting timelines ‱ Maintain current clinical trial management systems with site-specific information ‱ Provide expertise on local regulatory and legal requirements ‱ Ensure timely payment execution for assigned sites and studies ‱ Ensure adherence to regulations, GCPs, ICH Guidelines, SOPs, Monitoring Plans, and quality standards ‱ Stay current on evolving local regulations, guidelines, and policies ‱ Ensure audit and inspection readiness; advise on pre-audit GCP activities ‱ Prepare and follow up on site audits and inspections and provide input into CAPA preparation ‱ Coach and mentor CRAs and contribute to their development ‱ Serve as country point of contact for CROs when assigned ‱ Participate in or lead global and local task forces and initiatives ‱ Identify training needs and standardize and facilitate training solutions for SMM monitors when assigned ‱ Support onboarding and consolidate lessons learned into monitoring training materials and best-practice curricula when assigned ‱ Serve as a country or district study contact when assigned ‱ Update Impact/Tesla with country-level planning information and LSR assignments when assigned ‱ Act as global representative for studies when assigned ‱ Conduct remote data review according to IDRP, Monitoring Plan, SOP/WI, timelines, and study objectives when assigned ‱ Provide ongoing feedback on investigator and site performance ‱ Build professional and collaborative relationships with peers and site monitors

🎯 Requirements

‱ Bachelor's or equivalent degree in a health-related field (e.g. Medical, Scientific, Nursing, Pharmacy) preferred ‱ Minimum 3 years of site monitoring experience ‱ Strong analytical and critical thinking skills ‱ Excellent interpersonal and persuasive communication skills ‱ Flexibility and adaptability to changing requirements ‱ Resourcefulness and creativity ‱ Proactive and positive team-player approach ‱ Strong planning and organizational skills ‱ High level of flexibility in a dynamic environment with competing projects and deadlines ‱ Demonstrated business ethics and integrity ‱ Compliance with federal and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie SOPs, Monitoring Plans, and quality standards ‱ Knowledge of local regulatory and legal requirements ‱ Ability to ensure audit and inspection readiness

đŸ–ïž Benefits

‱ Remote work availability ‱ Equal opportunity employer ‱ Commitment to operating with integrity, driving innovation, transforming lives, and serving the community

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đŸ—ŁïžđŸ‡­đŸ‡ș Hungarian Required