Clinical Research Associate II

• Advance AbbVie's clinical development pipeline by striving for excellence in clinical research and turning science into medicine
• 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 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
• 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, scientific principles, and clinical trial requirements to day-to-day execution
• Evaluate and ensure recruitment and retention plans based on the patient disease journey
• Develop therapeutic area, asset, clinical landscape, and patient journey knowledge to support recruitment and protocol compliance
• 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
• Resolve site risk signals and implement preventative and corrective action plans
• Identify, evaluate, and recommend investigators and sites for planned clinical studies
• Ensure quality and timely submission of site data, safety-event reporting, and follow-up
• Maintain audit and regulatory inspection readiness at assigned clinical sites
• Manage investigator payments according to executed contract obligations, as applicable

• Appropriate tertiary qualification in health related disciplines (Medical, Scientific, Nursing) preferred
• Minimum of 1 year of clinically related experience
• At least 6 months of experience in clinical research monitoring of investigational drug or device trials
• 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 in a dynamic environment with competing projects and deadlines
• Advanced ability to leverage technology, tools, and resources
• Strong interpersonal skills with excellent written, verbal, active listening, and presentation skills
• Ability to establish and leverage site relationships and trusted partnerships through engagement, motivation, and training
• Ability to use functional expertise with guidance, apply critical thinking, and exercise good judgment to address clinical site issues
• 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