About the job
PRIMARY FUNCTION/OBJECTIVE
As a vital part of AbbVie's commitment to becoming a leading R&D organization, the Clinical Research Associate II will anticipate and proactively address clinical site challenges as they arise. This role involves initiating, recommending, and communicating corrective actions to ensure the successful execution of study protocols related to Clinical Site Management (CSM) deliverables throughout the start-up, execution, and close-out phases of clinical trials.
CORE JOB RESPONSIBILITIES
• Oversee activities at clinical investigative sites to ensure adherence to AbbVie clinical study protocols.
• Ensure compliance with federal and local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), Monitoring Plans, and quality standards in clinical research.
• Conduct site qualification, initiation, interim monitoring, and study closeout visits for Phase 1-4 studies according to applicable regulations and business processes.
• Manage site personnel indirectly, motivating and influencing them to meet study objectives, and implement action plans to ensure compliance.
• Maintain regulatory inspection readiness at assigned clinical sites.
• Assure quality and timeliness of data submission from study sites, including the follow-up on safety events reported by site personnel.
• Safeguard the well-being of study subjects by adhering to the monitoring plan, AbbVie SOPs, ICH Guidelines, and relevant regulations.

