Clinical Research Associate II – Oncology

🔥 0 minutes ago

🧀 Wisconsin – Remote

🧀 Wisconsin – 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 contextual clinical-trial information and connect stakeholders with investigative sites • Align, train, and motivate site staff and principal investigators on clinical-trial goals, protocols, and patient-treatment principles • Conduct site evaluation, site training, routine monitoring, and site-closure monitoring in compliance with protocols, regulations, GCP, ICH Guidelines, SOPs, and quality standards • Develop and customize site-engagement strategies for assigned studies • Gather local and site insights and use CRM tools to track progress and measure impact • Connect study protocols and scientific principles to day-to-day clinical-trial execution • Evaluate recruitment and retention plans based on the patient disease journey • 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 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 sites for planned clinical studies • Ensure quality and timely submission of site data, including safety-event reporting and follow-up • Maintain audit and regulatory-inspection readiness at assigned sites • Manage investigator payments according to executed contract obligations, as applicable

🎯 Requirements

• Minimum of 1 year of clinically related experience • At least 6 months of clinical research monitoring experience involving investigational drug or device trials • Familiarity with risk-based monitoring and onsite/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 manage competing projects and deadlines • Ability to leverage technology, tools, and resources for customer-centric site support • Strong interpersonal, written, verbal, active-listening, and presentation skills • Ability to establish site relationships and trusted partnerships through engagement, motivation, and training • Ability to apply critical thinking and good judgment to clinical-site issues • Integrity consistent with AbbVie’s code of business conduct and leadership values • Self-motivated approach focused on timely, quality outcomes • Appropriate tertiary qualification in a health-related discipline (Medical, Scientific, Nursing) preferred • Willingness and ability to travel 75% of the time

🏖️ Benefits

• Paid time off (vacation, holidays, sick) • Medical insurance • Dental insurance • Vision insurance • 401(k) • Short-term incentive programs • Remote work arrangement • Equal opportunity employer • Reasonable accommodations for US & Puerto Rico applicants