Clinical Research Associate II

🔥 5 minutes ago

🇹🇷 Turkey – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧪 Clinical Research

👻 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

• Anticipate and proactively solve study-related clinical site issues • Initiate, recommend, and communicate corrective actions for successful protocol execution • Monitor clinical investigative sites for adherence to protocols, regulations, ICH/GCP 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 influence them to meet study objectives • Manage sites and implement action plans to ensure compliance • Ensure regulatory inspection readiness at assigned clinical sites • Ensure quality and timely submission of study-site data • Ensure appropriate reporting and follow-up for safety events • Ensure safety and protection of study subjects • Train study site personnel on protocols and regulatory requirements • Manage investigator payments according to executed contracts • Negotiate investigator and hospital agreements with stakeholders • Complete expense reports according to local and applicable guidelines • Identify, evaluate, and recommend new or potential investigators and clinical 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 • Current in-depth knowledge of therapeutic indications relevant 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 and communication skills • Ability to address clinical site issues 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 • Commitment to operating with integrity, driving innovation, transforming lives and serving the community

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