Clinical Research Associate II

• Advance AbbVie’s clinical pipeline through excellence in clinical research and advanced capabilities
• Serve as the primary point of contact for the investigative site
• Provide contextual information on clinical trials and connect stakeholders with investigative sites
• Align, train and motivate site staff and principal investigators on trial goals, protocol and patient treatment principles
• Conduct site evaluation, site training, routine monitoring and site closure activities
• Ensure compliance with protocols, monitoring plans, applicable regulations, GCPs, ICH Guidelines, AbbVie SOPs and quality standards
• Develop and customize site engagement strategies for assigned studies
• Gather local and site insights; use CRM tools to track progress and measure impact
• Connect study protocols, scientific principles and clinical trial requirements to daily trial execution
• Evaluate and ensure effective patient recruitment and retention techniques/plans
• Develop therapeutic-area, asset, clinical-landscape and patient-journey knowledge
• Mentor and train less experienced CRAs and contribute to their development
• Participate in global/local task forces and initiatives
• Conduct continuous risk assessment with the Central Monitoring team to detect study-performance or patient-safety issues
• Resolve site risk signals and implement preventative and corrective action plans
• Identify, evaluate and recommend potential investigators and sites
• Ensure quality and timely submission of site data, 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
• Perform additional activities assigned by the manager

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

• Employees can work remotely
• Equal opportunity employer
• Commitment to operating with integrity, driving innovation, transforming lives and serving the community