Clinical Research Associate II

• Advance AbbVie’s clinical development pipeline in immunology by supporting excellence in clinical research
• Partner with study teams, internal R&D stakeholders, investigators, and site staff
• Serve as the primary sponsor point of contact for investigative sites
• Align, train, and motivate site staff and principal investigators on trial goals, protocols, and patient treatment principles
• Support, guide, and mentor junior personnel on site management activities
• Conduct site evaluation, site training, routine on-site and off-site monitoring, and site closure monitoring
• Ensure compliance with protocols, monitoring plans, regulations, GCP, ICH Guidelines, SOPs, and quality standards
• Develop and customize site engagement strategies; gather site insights and track strategy impact
• Generate and implement patient recruitment and retention techniques based on the disease journey
• Mentor and train less experienced CRAs and support local onboarding
• Participate in or lead global/local task forces and initiatives
• Conduct continuous risk assessments with the Central Monitoring team
• Identify, evaluate, and recommend investigators and sites
• Ensure data quality, timely data submission, 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
• Implement preventative and corrective action plans to mitigate risk and promote compliance

• Appropriate tertiary qualification in a health-related discipline (e.g., Medical, Scientific, Pharmacy, Nursing) preferred
• Minimum of 3 years of clinically related experience
• Preferably 2 years of independent clinical research monitoring experience for investigational drug or device trials
• Familiarity with risk-based monitoring and on-site/off-site monitoring
• Knowledge of therapeutic area indications and ability to apply scientific concepts to clinical trials
• Knowledge of local regulatory and legal requirements, ICH/GCP Guidelines, and applicable policies
• Advanced communication and cross-functional collaboration skills
• Strong planning and organizational skills; ability to work effectively with competing projects and deadlines
• Ability to leverage technology, tools, and resources for site support
• Excellent written, verbal, active listening, presentation, interpersonal, and relationship-building skills
• Ability to independently address clinical site issues using functional expertise, critical thinking, and judgment
• Integrity in accordance with AbbVie’s code of business conduct and leadership values
• Self-motivated and focused on timely, quality outcomes
• Ability to work remotely

• Remote work option
• Equal opportunity employment
• Support for reasonable accommodations for US & Puerto Rico applicants
• Referral opportunity/program