Clinical Research Associate II

• Advance AbbVie’s clinical research pipeline by striving for excellence in clinical research and leveraging advanced capabilities
• Partner with investigators and site staff to establish meaningful and effective engagements
• 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, 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, AbbVie SOPs and quality standards
• Customize site engagement strategies and use CRM tools to report progress and measure impact
• Connect study protocols, scientific principles and clinical trial requirements to day-to-day 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/local task forces and initiatives as assigned
• 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 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 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 clinical research monitoring experience for 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
• 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 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 clinical site issues
• Integrity in accordance with AbbVie code of business conduct and leadership values
• Self-motivated; focused on timely and 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