Clinical Research Associate II

Role Summary

The Clinical Research Associate II supports AbbVie's clinical trials by coordinating site engagement, monitoring, and data quality to ensure compliant execution and robust patient safety. They act as primary liaison with investigative sites, train site staff and investigators, and collaborate with central monitoring to manage risk and study performance. They mentor junior CRAs, identify potential investigators, and drive recruitment and retention strategies to support protocol adherence.

Responsibilities

• Primary point of contact for the investigative site, providing contextual information on trials and connecting stakeholders to the sites to strengthen AbbVie’s positioning.
• Aligns, trains and motivates site staff and the principal investigator on trial goals, protocol and patient treatment principles to establish a trusted partnership.
• Conducts site evaluation, training, routine monitoring, and site closure activities with compliance to the protocol, monitoring plans, GCP/ICH guidelines, SOPs, and quality standards to safeguard study subjects.
• Advanced understanding of site engagement and ability to customize engagement strategy for assigned studies; gather local insights and use site engagement tools (CRM) to report, track progress, and measure impact.
• Connects the study protocol and scientific principles to day-to-day trial execution; evaluates and ensures recruitment and retention techniques based on the patient journey; develops knowledge of therapeutic area to enable recruitment and protocol compliance.
• Mentors and trains less experienced CRAs; may participate in global/local task forces and initiatives; performs activities as assigned by the manager.
• Proactively conducts continuous risk assessment and, with the Central Monitoring team, monitors site activities to detect early study performance or patient safety issues.
• Thinks critically to resolve site risk signals, understands site processes, and implements preventative and corrective actions to mitigate risk and promote compliance with a customer-centric approach.
• Identifies, evaluates and recommends new investigators/sites; may identify sites through networking or internal requests to support study placement.
• Ensures data quality and timely submission from study sites, including safety reporting; maintains audit/regulatory inspection readiness and manages investigator payments per contract obligations where applicable.

Qualifications

• Appropriate tertiary qualification in health-related disciplines (Medical, Scientific, Nursing) preferred.
• Minimum of 1 year of clinically related experience, including at least 6 months in clinical research monitoring of investigational drug or device trials; familiar with risk-based monitoring, onsite and offsite monitoring.
• Knowledge of therapeutic area indications is preferred with ability to apply scientific concepts to trial conduct.
• Advanced knowledge of local regulatory and legal requirements, ICH/GCP Guidelines and applicable policies.
• Demonstrate strong cross-functional collaboration skills among internal and external stakeholders.
• Demonstrate strong planning and organizational skills and the ability to work effectively in a dynamic environment with competing projects and deadlines.
• Advanced ability to leverage 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; ability to establish site relationships and trusted partnerships through engagement, motivation, and training.
• Ability to use functional expertise with appropriate guidance, leverage critical thinking skills and apply good judgment to address clinical site issues.
• Acts with integrity in accordance with AbbVie code of business conduct and leadership values; self-motivated with a focus on delivering timely, quality outcomes in a fast-paced environment.