Clinical Research Associate II

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AbbVie

WebsiteLinkedInAll Job Openings

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 conducted by clinical investigative sites for AbbVie clinical studies • Ensure protocol execution and adherence to federal and local regulations, GCPs, ICH Guidelines, AbbVie SOPs, monitoring plans, and quality standards • Conduct site qualification, initiation, interim monitoring, and study closeout visits for Phase I to III studies • Oversee site personnel activities and implement action plans to ensure compliance • Ensure regulatory inspection readiness at assigned clinical sites • Ensure quality and timely submission of site data, including safety-event reporting and follow-up • Protect study subjects through compliance with monitoring plans, SOPs, ICH Guidelines, and applicable regulations • Train study site personnel on protocols and regulatory requirements • Manage investigator payments and negotiate investigator/hospital agreements • Complete expense reports • Identify, evaluate, and recommend new investigators and clinical sites

🎯 Requirements

• Appropriate tertiary qualification in a health-related field preferred, such as Medical, Scientific, or Nursing • Minimum 2 years of clinically related monitoring experience • Experience with on-site monitoring of investigational drug or device trials required • In-depth knowledge of therapeutic indications relevant to clinical trials • In-depth knowledge of clinical research regulations, ICH/GCP Guidelines, and applicable regulations • Familiarity with study monitoring, data, drug accountability, and documentation • Strong planning and organizational skills • Ability to work effectively in a dynamic environment with competing projects and deadlines • Ability to understand and follow work processes • Strong analytical and conceptual capabilities • Interpersonal skills and clear communication ability • Ability to address clinical site issues and communicate corrective actions • Ability to exercise good judgment • Demonstrated business ethics and integrity • Minimum 50% travel required • Proficiency with Microsoft Office Suite, including Outlook, PowerPoint, Excel, and Word • Comfort using various technologies and systems for day-to-day tasks • Valid driver’s license and passport

🏖️ Benefits

• Remote work option • Equal opportunity employment • Reasonable accommodation for applicants with disabilities