Clinical Research Associate II

Location: North Chicago, Illinois, United States; Wuhan, China

Company

AbbVie develops innovative medicines and healthcare solutions in areas including immunology, oncology, neuroscience, and aesthetics.

What you will do

• Serve as the primary point of contact for investigative sites and build effective partnerships with investigators and site staff.
• Align, train, and motivate site personnel on clinical trial goals, protocols, and patient treatment principles.
• Conduct site evaluation, training, routine monitoring, and site closure activities in accordance with protocols, monitoring plans, GCP, ICH guidelines, regulations, and SOPs.
• Support patient recruitment and retention by applying knowledge of the therapeutic area, patient journey, and clinical landscape.
• Perform continuous risk assessment, resolve site risk signals, and implement preventative and corrective action plans.
• Ensure data quality and timely safety reporting, maintain inspection readiness, identify qualified investigators and sites, and manage investigator payments when applicable.

Requirements

• At least 1 year of clinically related experience, including at least 6 months of monitoring investigational drug or device trials.
• Experience with risk-based monitoring and onsite and offsite monitoring.
• Advanced knowledge of local regulatory and legal requirements, ICH/GCP guidelines, and applicable policies.
• Strong planning, organization, critical thinking, judgment, communication, presentation, and stakeholder collaboration skills.
• Ability to use clinical research technologies and tools to support site engagement and study execution.
• A tertiary qualification in a health-related discipline such as medicine, science, or nursing is preferred.

Culture & Benefits

• Work is focused on integrity, innovation, patient safety, data quality, and regulatory compliance.
• Opportunity to mentor less experienced CRAs and participate in global or local task forces and initiatives.
• Work involves collaboration with investigators, site staff, central monitoring teams, and cross-functional stakeholders.