Clinical Research Associate II

• Advance AbbVie’s clinical development pipeline through excellence in clinical research
• Partner with study teams, AbbVie 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 clinical 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, applicable regulations, GCP, ICH Guidelines, AbbVie SOPs, and quality standards
• Customize site engagement strategies and track their progress and impact
• Apply protocol, scientific, and clinical-trial knowledge to daily trial execution
• Develop recruitment and retention techniques based on the patient disease journey
• Mentor and train less experienced CRAs and support onboarding of junior CRAs
• Participate in or lead global and local task forces and initiatives
• Conduct continuous risk assessments with the Central Monitoring team
• Identify, evaluate, and recommend investigators and clinical trial sites
• Ensure data quality, timely data submission, and appropriate safety-event reporting and follow-up
• Maintain audit and regulatory inspection readiness
• Manage investigator payments according to executed contract obligations, where applicable

• Appropriate tertiary qualification in health related disciplines (e.g., Medical, Scientific, Pharmacy, Nursing) preferred
• Minimum of 3 years of clinically related experience
• Preferably 2 years of independent clinical research monitoring of investigational drug or device trials
• Familiarity with risk-based monitoring approach, onsite and offsite monitoring
• Knowledge of therapeutic area indications and ability to apply scientific concepts to clinical trial conduct
• Knowledge of local regulatory and legal requirements, ICH/GCP Guidelines, and applicable policies
• Advanced communication and superior cross-functional collaboration skills
• Superior planning and organizational skills
• Ability to work effectively in a dynamic environment with competing projects and deadlines
• Ability to leverage technology, tools, and resources for customer-centric site support
• Superior interpersonal, written, verbal, active listening, and presentation skills
• Ability to establish site relationships and trusted partnerships through engagement, motivation, and training
• Ability to independently address clinical site issues using functional expertise, critical thinking, and good judgment
• Integrity consistent with AbbVie’s code of business conduct and leadership values
• Self-motivated and focused on timely, quality outcomes in a fast-paced environment

• Equal opportunity employer
• Commitment to operating with integrity, driving innovation, transforming lives, and serving the community
• Remote work availability