Clinical Research Associate II

🔥 12 minutes ago

🌽 Illinois – Remote

🌽 Illinois – Remote

💵 $84.5k - $162k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧪 Clinical Research

🚫👨‍🎓 No degree required

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 0%

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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

• Advance AbbVie’s clinical development pipeline by supporting excellence in clinical research • Serve as the primary point of contact for investigative sites • Provide contextual information on clinical trials and connect stakeholders with investigative sites • Align, train, and motivate site staff and principal investigators on trial goals, protocols, and patient treatment principles • Conduct site evaluation, site training, routine monitoring, and site closure monitoring • Ensure compliance with protocols, monitoring plans, regulations, GCPs, ICH Guidelines, SOPs, and quality standards • Develop and customize site engagement strategies for assigned studies • Gather site insights and use CRM tools to report and track progress and measure impact • Connect study protocols, scientific principles, and trial requirements to daily trial execution • Evaluate recruitment and retention techniques based on the patient disease journey • Develop therapeutic-area, asset, clinical-landscape, and patient-journey knowledge • Mentor and train less experienced CRAs and contribute to their development • Participate in global or local task forces and initiatives • Conduct continuous risk assessment with the Central Monitoring team • Detect study-performance or patient-safety issues and resolve site risk signals • Implement preventative and corrective action plans to mitigate risk and promote compliance • Identify, evaluate, and recommend investigators and clinical sites • Ensure quality and timely submission of site data and safety-event reporting • Maintain audit and regulatory inspection readiness at assigned sites • Manage investigator payments as applicable

🎯 Requirements

• Minimum of 1 year of clinically related experience • At least 6 months of clinical research monitoring of investigational drug or device trials • Familiarity with risk-based monitoring, onsite and offsite monitoring • Advanced knowledge of local regulatory and legal requirements, ICH/GCP Guidelines, and applicable policies • Knowledge of appropriate therapeutic area indications preferred • Appropriate tertiary qualification in health-related disciplines (Medical, Scientific, Nursing) preferred • Strong cross-functional collaboration skills • Strong planning and organizational skills • Ability to work effectively in a dynamic environment with competing projects and deadlines • Advanced ability to leverage technology, tools, and resources • Strong interpersonal, written, verbal, active listening, and presentation skills • Ability to establish and leverage site relationships and trusted partnerships • Ability to apply critical thinking and good judgment to address clinical site issues • Self-motivated and focused on timely, quality outcomes • Acts with integrity in accordance with AbbVie code of business conduct and leadership values

🏖️ Benefits

• Paid time off (vacation, holidays, sick) • Medical, dental, and vision insurance • 401(k) • Short-term incentive programs • Equal opportunity employer • Reasonable accommodation for US & Puerto Rico applicants