Clinical Research Associate II

🔥 1 minute ago

🇨🇦 Canada – Remote

💵 $81k - $131k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧪 Clinical Research

🚫👨‍🎓 No degree required

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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

• Proactively solve study-related clinical site issues and initiate, recommend, and communicate corrective action • Monitor activities conducted by clinical investigative sites for successful protocol execution • Ensure 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 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 quality and timely submission of study-site data, including safety-event reporting and follow-up • Ensure safety and protection of study subjects through monitoring-plan, SOP, guideline, and regulatory compliance • Train study-site personnel on protocols and regulatory requirements • 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 new/potential investigators and sites

🎯 Requirements

• Appropriate tertiary qualification, health related (e.g., Medical, Scientific, Nursing) preferred • 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 and understanding of appropriate therapeutic indications as they relate to the conduct of clinical trials • 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 and ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines • Ability to work, understand and follow work processes within the assigned function • Strong analytical and conceptual capabilities, interpersonal skills, and ability to communicate with clarity • Ability to address study related clinical site issues with appropriate guidance and initiate and communicate corrective action as indicated • Ability to use functional expertise and exercise good judgment • Demonstrated business ethics and integrity • A minimum of 50% travel is required • Proficient with Microsoft Office Suite (Outlook, PowerPoint, Excel, Word, etc.) • Must be at ease with technology (the use of various tools/systems to perform day-to-day tasks) • Valid driver’s license and passport

🏖️ Benefits

• Innovative work culture • Professional development • Paid time off: vacation, holidays, personal days, and volunteer days • Employee stock purchase • Wellness spending account • Flexible health insurance • Retirement savings programs • Bonus plan

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