Clinical Research Associate II- Immunology - Chicago; Remote

Job Purpose

Advance Abb Vie's pipeline by striving for excellence in clinical research, turning science into medicine for our patients and leveraging new advanced capabilities to drive industry‑leading performance. Partner with investigators and site staff for meaningful and effective engagements positioning Abb Vie as the choice in clinical trials. Focus on site clinical research that ensures appropriate conduct of the trial while driving improvement in data integrity, compliance, overall study performance, and customer experience.

• Act as the primary point of contact for the investigative site; provide contextual information on clinical trials, connect stakeholders, and strengthen Abb Vie’s positioning.
• Align, train and motivate site staff and principal investigator on the goals of the clinical trial program, protocol, and patient treatment principles, ensuring a trusted partnership.
• Conduct site evaluation, site training, routine monitoring, and site‑closure monitoring activities in compliance with protocol, monitoring plans, regulations, GCPs, ICH Guidelines, Abb Vie SOPs, and quality standards, ensuring safety and protection of study subjects.
• Apply advanced understanding of site engagement and customize site engagement strategy for assigned studies; gather local/site insights and use CRM tools to report, track, and measure strategy impact.
• Link study protocol, scientific principles, and trial requirements to day‑to‑day execution; evaluate and ensure effective recruitment and retention techniques based on the patient disease journey; develop solid knowledge of therapeutic area, asset, and clinical landscape to enable successful recruitment and protocol compliance.
• Mentor and train less experienced CRAs on various aspects of work, provide input into their development, and participate in global/local task forces and initiatives as assigned.
• Continuously assess risk proactively; collaborate with Central Monitoring team to detect early overall study performance or patient safety issues at sites.
• Use critical thinking to resolve site risk signals while applying robust understanding of site processes to drive study execution; ensure preventive and corrective action plans are implemented to mitigate risk and promote compliance.
• Identify, evaluate, and recommend new/potential investigators and sites on an ongoing basis, sourcing potential sites through networking or Abb Vie requests.
• Ensure quality of data submitted from study sites, timely data submission, appropriate reporting, and follow‑up for all safety events; maintain audit and regulatory inspection readiness and manage investigator payments per contract obligations.

• Appropriate tertiary qualification in health‑related disciplines (Medical, Scientific, Nursing) preferred.
• Minimum of 1 year of clinically related experience, with at least 6 months in clinical research monitoring of investigational drug or device trials; familiar with risk‑based monitoring approach, onsite and offsite monitoring.
• Knowledge of relevant therapeutic area indications preferred, with ability to understand and apply scientific concepts in trial conduct.
• Advanced knowledge of local regulatory and legal requirements, ICH/GCP Guidelines, and applicable policies.
• Strong cross‑functional collaboration skills with internal and external stakeholders.
• Excellent planning and organizational skills; able to work effectively in a dynamic environment with competing projects and deadlines.
• Proficiency in leveraging technology, tools, and resources to provide customer‑centric support based on site health.
• Strong interpersonal skills with excellent written, verbal, active‑listening, and presentation skills to build trusted partnerships through engagement, motivation, and training.
• Ability to exercise functional expertise, critical thinking, and good judgement to address clinical site issues.
• Acts with integrity in accordance with Abb Vie’s code of business conduct and leadership values; a self‑motivated individual focused on delivering timely, quality outcomes in a fast‑paced environment.

• The compensation range described below is the range of…