Clinical Research Associate II

About the role

AbbVie is seeking a Clinical Research Associate II to support Phase 1‑4 studies across its therapeutic areas. The CRA will ensure protocol compliance, data quality, and patient safety through proactive site monitoring and close collaboration with investigators.

Key responsibilities

• Anticipate and resolve study‑related site issues, initiating corrective actions to keep studies on track.
• Monitor clinical investigative sites to ensure adherence to federal and local regulations, Good Clinical Practice (GCP), ICH Guidelines, and AbbVie SOPs.
• Conduct site qualification, initiation, interim monitoring, and close‑out visits for Phase 1‑4 studies.
• Motivate and influence site personnel to meet study objectives and maintain regulatory inspection readiness.
• Ensure timely, high‑quality data submission and safety event reporting from sites.
• Train site staff on protocol specifics and regulatory requirements in partnership with the project team.
• Manage investigator payments, negotiate agreements, and maintain expense reports.
• Identify and evaluate new potential investigators and sites to support future study placements.

Required profile

• Relevant tertiary qualification in a health‑related discipline (e.g., medical, scientific, nursing) preferred.
• Minimum of 1 year of clinically related experience, including at least 6 months of clinical research monitoring.
• Demonstrated ability to travel to and work with multiple clinical sites.
• Strong organizational and communication skills to coordinate with cross‑functional teams.

Required skills

• Knowledge of Good Clinical Practice (GCP) and ICH Guidelines.
• Familiarity with AbbVie Standard Operating Procedures (SOPs) and monitoring plans.
• Experience conducting site qualification, initiation, monitoring, and close‑out activities.
• Ability to manage regulatory documentation and ensure inspection readiness.