Clinical Research Associate II

🔥 0 minutes ago

🌲 North Carolina – Remote

🌲 North Carolina – Remote

💵 $84.5k - $162k / 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

• Serve as the primary point of contact for investigative sites. • Provide clinical trial context 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 activities. • Ensure compliance with protocols, monitoring plans, regulations, GCPs, ICH Guidelines, SOPs, and quality standards. • Develop and execute customized site engagement strategies. • Gather site insights and use CRM tools to track progress and measure impact. • Evaluate recruitment and retention techniques based on the patient disease journey. • Mentor and train less experienced CRAs. • Participate in global/local task forces and initiatives. • Conduct continuous risk assessment and collaborate with Central Monitoring to identify study performance or patient safety issues. • Implement preventative and corrective action plans to mitigate risk and promote compliance. • Identify, evaluate, and recommend investigators and clinical trial sites. • Ensure quality and timely submission of site data and safety event reports. • Maintain audit and regulatory inspection readiness. • Manage investigator payments as applicable.

🎯 Requirements

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

🏖️ Benefits

• Paid time off (vacation, holidays, sick) • Medical, dental, and vision insurance • 401(k) • Short-term incentive programs • Remote work arrangement