Clinical Research Associate II

🔥 0 minutes ago

🇹🇷 Turkey – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧪 Clinical Research

👻 Ghost score 10%

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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

• Proactively solve study-related clinical site issues and recommend corrective actions • Monitor clinical investigative sites for protocol compliance and successful study execution • Ensure adherence to regulations, ICH/GCP Guidelines, AbbVie SOPs, monitoring plans, and quality standards • Conduct site qualification, initiation, interim monitoring, and closeout visits for Phase 1–4 studies • Manage and influence site personnel without direct authority to meet study objectives • Ensure regulatory inspection readiness at assigned clinical sites • Ensure quality and timely submission of study data and safety event reporting • Protect study subjects through compliance with monitoring plans, SOPs, guidelines, and regulations • Train study site personnel on protocols and regulatory requirements • Manage investigator payments and negotiate investigator/hospital agreements • Complete expense reports according to applicable guidelines • Identify, evaluate, and recommend new investigators and clinical research sites

🎯 Requirements

• Bachelor’s degree in a scientific or related field • Minimum of 1 year of clinically-related experience • 6 months of clinical research monitoring experience preferred • Experience in on-site monitoring of investigational drug or device trials required • Fluent in English, both written and verbal • In-depth knowledge of therapeutic indications relevant to clinical trials • 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 and communication skills • Ability to address clinical site issues and initiate and communicate corrective actions • Ability to use functional expertise and exercise good judgment • Demonstrated business ethics and integrity

🏖️ Benefits

• Remote work option • Equal opportunity employment • Reasonable accommodation for US & Puerto Rico applicants • Veterans/Disabled employment protections

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