Clinical Research Associate ll - Oncology; North Carolina​/South Carolina

Clinical Research Associate II – Oncology (North Carolina/South Carolina)

Abb Vie’s mission is to discover and deliver innovative medicines. The Clinical Research Associate II (CRA II) advances Abb Vie’s pipeline through superior clinical research, partner with investigators and site staff, and drive performance.

The CRA II focuses on site clinical research, ensuring proper trial conduct, improving data integrity, compliance, study performance, and the customer experience.

• Primary point of contact for investigative site, providing contextual trial information and strengthening Abb Vie positioning.
• Aligns, trains, and motivates site staff and principal investigator on trial goals and protocol, fostering a trusted partnership.
• Conduct site evaluation, training, routine monitoring, and closure activities in compliance with protocol, SOPs, GCP, and regulations.
• Customizes site engagement strategy, gather local insights, and uses CRM to track progress and measure impact.
• Connects study protocol and scientific principles to day‑to‑day execution, ensuring effective recruitment and retention methods.
• Mentors and trains less experienced CRAs, providing input into their development.
• Participates in task forces and initiatives; performs manager assigned activities.
• Performs continuous risk assessment proactively, in collaboration with Central Monitoring.
• Resolves site risk signals, implements corrective action plans, and promotes compliance.
• Identifies, evaluates, and recommends new investigators/sites, assisting placement of studies.
• Ensures quality data submission, timely reporting of safety events, and audit readiness.
• Manages investigator payments per contract obligations.

• Minimum of 1 year of clinically related experience, including 6 months in clinical research monitoring of investigational drug or device trials (CRA experience).
• Familiar with risk‑based monitoring approach, onsite and offsite monitoring.

• Appropriate tertiary qualification in health‑related disciplines (Medical, Scientific, Nursing).
• Knowledge of oncology indications and ability to apply scientific concepts to trial conduct.
• Experience as a study coordinator.

• Advanced knowledge of regulatory requirements, ICH/GCP guidelines, and policies.
• Strong cross‑functional collaboration skills with internal and external stakeholders.
• Strong planning and organizational skills in a dynamic environment with competing projects.
• Ability to leverage technology and resources for customer‑centric support.
• Excellent interpersonal, written, verbal, active listening, and presentation skills.
• Critical thinking and good judgment to address site issues.
• Acts with integrity per Abb Vie code of conduct and leadership values.
• Self‑motivated and focused on delivering timely and quality outcomes.

• The compensation range described below reflects the base pay that Abb Vie believes in good faith it will pay for this role, subject to factors such as location. The range may be modified in the future.
• Benefits include paid time off, medical/dental/vision insurance, and 401(k) for eligible employees.
• Participation in short‑term and long‑term incentive programs is eligible.

Abb Vie is an equal‑opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, and serving our community.

Equal Opportunity Employer/Veterans/Disabled.

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