Clinical Research Associate II

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AbbVie

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 2013

💊 Pharmaceuticals

🧬 Biotechnology

⚕️ Healthcare Insurance

Pharmaceuticals • Biotechnology • Healthcare Insurance

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

• Monitors activities conducted by clinical investigative sites as they relate to AbbVie clinical studies to ensure successful execution of the protocol. • Ensures adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), Monitoring Plans, and to quality standards in conducting clinical research. • Conducts site qualification, initiation, interim monitoring and study closeout visits for Phase I to III studies in accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, and AbbVie Standard Operating Procedures (SOPs) and business processes. • Ensures regulatory inspection readiness at assigned clinical sites. • Ensures quality of data submitted from study sites and assures timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel. • Trains study site personnel on the protocol and applicable regulatory requirements in collaboration with pertinent project team members. • Identifies, evaluates and recommends new/potential investigators/sites on an ongoing basis.

🎯 Requirements

• Minimum of 2 years of clinically-related monitoring experience. • Experience in on-site monitoring of investigational drug or device trials is required. • Current in-depth knowledge of regulations governing clinical research, ICH/GCP Guidelines and applicable regulations. • Familiarity with all aspects of study monitoring; data, drug accountability, documentation experience. • Strong planning and organizational skills. • Ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines. • Ability to address study related clinical site issues with appropriate guidance and initiates and communicate corrective action as indicated. • A minimum of 50% travel is required. • Proficient with Microsoft Office Suite (Outlook, PowerPoint, Excel, Word, etc.)

🏖️ Benefits

• Health insurance • 401(k) matching • Flexible working hours • Paid time off