Clinical Research Associate ll - Oncology (North Carolina/South Carolina)

Role Summary

Clinical Research Associate II - Oncology (North Carolina/South Carolina) with AbbVie. The CRA II advancesAbbVie’s pipeline by striving for excellence in clinical research, ensuring proper trial conduct, and continually improving data integrity, compliance, and study performance while enhancing the customer experience. Partners with investigators and site staff to build meaningful engagements and position AbbVie as the sponsor of choice in clinical trials.

Responsibilities

• Primary point of contact for the investigative site; provide contextual information on clinical trials and strengthen AbbVie‚Äôs position.
• Align, train, and motivate site staff and principal investigator on trial goals, protocol, and patient treatment principles to foster a trusted partnership.
• Conduct site evaluation, training, routine monitoring, and site closure activities with compliance to protocol, monitoring plans, and regulatory standards to ensure subject safety.
• Customize site engagement strategies, gather local insights, and use engagement tools (CRM) to report progress and measure impact.
• Connect study protocol and scientific principles to day-to-day trial execution; develop recruitment and retention techniques based on patient journey; maintain protocol compliance.
• Mentor and train less experienced CRAs and contribute to their development.
• Participate in global/local task forces; perform assigned activities by manager.
• Continuously assess risk; monitor site performance and patient safety issues in collaboration with Central Monitoring.
• Think critically to resolve site risk signals; implement preventive and corrective actions to mitigate risk and ensure compliance.
• Identify and evaluate new investigators/sites; assist in placement of studies with qualified investigators.
• Ensure data quality and timely data submission; manage safety reporting and follow-up.
• Ensure audit and regulatory inspection readiness at assigned sites.
• Manage investigator payments per contract obligations where applicable.

Qualifications

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

Preferred Qualifications

• Health-related tertiary qualification (Medical, Scientific, Nursing) preferred.
• Knowledge of oncology indications; ability to apply scientific concepts to trial conduct.
• Experience as a study coordinator.

Other Required Skills

• Advanced knowledge of local regulatory and legal requirements, ICH/GCP Guidelines, and applicable policies.
• Strong cross-functional collaboration; excellent planning and organizational skills; ability to manage multiple projects and deadlines.
• Proficient with technology and tools to provide customer-centric site support.
• Strong interpersonal, written, verbal, listening, and presentation skills; ability to build trusted site relationships.
• Analytical judgment and problem-solving abilities to address clinical site issues.
• Integrity and adherence to AbbVie code of conduct; self-motivated with focus on timely, quality outcomes in a fast-paced environment.