Clinical Research Associate II - Oncology PA

About the role

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

Responsibilities

• Serve as the primary point of contact for investigative sites.
• Maintain a high level of competency in providing contextual information on clinical trials, connecting stakeholders to investigative sites, and strengthening AbbVie’s positioning.
• Align, train, and motivate site staff and principal investigators on trial goals, protocol, and patient treatment principles to ensure a trusted partnership.
• Conduct site evaluation, training, routine monitoring, and site closure activities in compliance with protocol, monitoring plans, applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie SOPs, and quality standards, ensuring subject safety and protection.
• Apply an advanced understanding of site engagement and customize site engagement strategies for assigned studies; gather local/site insights and use CRM tools to report progress and measure impact.
• Demonstrate an advanced level of competency in connecting study protocol, scientific principles, and clinical trial requirements to day-to-day execution activities.
• Evaluate and ensure effective recruitment and retention techniques based on the patient disease journey; develop knowledge of therapeutic area, asset, and clinical landscape to enable successful patient recruitment and protocol compliance.
• Mentor less experienced CRAs and provide input into their development; may participate in global/local task forces and initiatives.
• Conduct continuous risk assessments in collaboration with the Central Monitoring team to detect early study performance or patient safety issues; resolve site risk signals with robust understanding of site processes.
• Identify, evaluate, and recommend new or potential investigators/sites through networking or internal requests to support placement of planned clinical studies with qualified investigators.
• Ensure quality of data submitted from study sites, timely data submission, appropriate reporting and follow-up for safety events, audit readiness, and regulatory inspection readiness at assigned sites.
• Manage investigator payments in accordance with executed contract obligations, as applicable.

Requirements

• Appropriate tertiary qualification in a health-related discipline (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.
• Familiarity with risk-based monitoring approaches, including onsite and offsite monitoring.
• Knowledge of appropriate therapeutic area indications preferred, with the ability to understand and apply scientific concepts to clinical trial conduct.
• Advanced knowledge of local regulatory and legal requirements, ICH/GCP Guidelines, and applicable policies.
• Strong cross-functional collaboration skills among internal and external stakeholders.
• Strong planning and organizational skills with 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.
• Excellent interpersonal, written, verbal, active listening, and presentation skills; ability to establish and leverage site relationships through engagement, motivation, and training.
• Ability to use functional expertise with appropriate guidance, leverage critical thinking, and apply good judgment to address clinical site issues.
• Acts with integrity in accordance with AbbVie’s code of business conduct and leadership values.