Clinical Research Associate

🕒 6 days ago

🇵🇱 Poland – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧪 Clinical Research

🚫👨‍🎓 No degree required

👻 Ghost score 10%

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Logo of AbbVie

AbbVie

10,000+ employees

Founded 2013

🏥 Healthcare

💼 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

• Monitor activities at clinical investigative sites for AbbVie clinical studies to ensure successful protocol execution • Ensure adherence to federal and local regulations, Good Clinical Practices, ICH Guidelines, AbbVie SOPs, monitoring plans, and quality standards • Conduct site qualification, initiation, interim monitoring, and study closeout visits for Phase 1–4 studies • Oversee site personnel activities and motivate/influence them to meet study objectives • Proactively manage sites and implement action plans to ensure compliance • Ensure regulatory inspection readiness at assigned clinical sites • Ensure data quality and timely submission, including safety-event reporting and follow-up • Ensure study-subject safety and protection through compliance with monitoring plans, SOPs, guidelines, and regulations • Train site personnel on protocols and regulatory requirements with project team members • Manage investigator payments according to executed contract obligations • Negotiate investigator/hospital agreements with stakeholders • Complete expense reports according to local and applicable guidelines • Identify, evaluate, and recommend potential investigators and clinical sites

🎯 Requirements

• Appropriate tertiary qualification, health related (e.g., Medical, Scientific, Nursing) preferred • Minimum of 1 year of clinically-related experience, with 6 months preferable in clinical research monitoring • Experience in on-site monitoring of investigational drug or device trials required • Current in-depth knowledge of appropriate therapeutic indications related to clinical trials • Current in-depth knowledge of clinical research regulations, ICH/GCP Guidelines, and applicable regulations • Strong planning and organizational skills • Ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines • Ability to understand and follow work processes within the assigned function • Strong analytical and conceptual capabilities • Strong interpersonal skills and ability to communicate with clarity • Ability to address clinical site issues with appropriate guidance and initiate and communicate corrective action • Ability to use functional expertise and exercise good judgment • Demonstrated business ethics and integrity

🏖️ Benefits

• Employees can work remotely • Equal opportunity employer committed to operating with integrity, driving innovation, transforming lives and serving the community

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