Clinical Research Associate II

• Proactively solve study-related clinical site issues and recommend corrective actions
• Monitor clinical investigative sites for protocol compliance and successful study execution
• Ensure adherence to regulations, ICH/GCP Guidelines, AbbVie SOPs, monitoring plans, and quality standards
• Conduct site qualification, initiation, interim monitoring, and closeout visits for Phase 1–4 studies
• Manage and influence site personnel without direct authority to meet study objectives
• Ensure regulatory inspection readiness at assigned clinical sites
• Ensure quality and timely submission of study data and safety event reporting
• Protect study subjects through compliance with monitoring plans, SOPs, guidelines, and regulations
• Train study site personnel on protocols and regulatory requirements
• Manage investigator payments and negotiate investigator/hospital agreements
• Complete expense reports according to applicable guidelines
• Identify, evaluate, and recommend new investigators and clinical research sites

• Bachelor’s degree in a scientific or related field
• Minimum of 1 year of clinically-related experience
• 6 months of clinical research monitoring experience preferred
• Experience in on-site monitoring of investigational drug or device trials required
• Fluent in English, both written and verbal
• In-depth knowledge of therapeutic indications relevant to clinical trials
• In-depth knowledge of clinical research regulations, ICH/GCP Guidelines, and applicable regulations
• Strong planning and organizational skills
• Ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines
• Ability to understand and follow work processes within the assigned function
• Strong analytical and conceptual capabilities
• Strong interpersonal and communication skills
• Ability to address clinical site issues and initiate and communicate corrective actions
• Ability to use functional expertise and exercise good judgment
• Demonstrated business ethics and integrity

• Remote work option
• Equal opportunity employment
• Reasonable accommodation for US & Puerto Rico applicants
• Veterans/Disabled employment protections