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 our patients and leveraging new advanced capabilities to drive industry leading performance. Partners with the investigator and site staff for meaningful and effective engagements positioning AbbVie 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.

Responsibilities

• Primary point of contact for the investigative site.
• Provide high-level competency and contextual information on clinical trials, connect stakeholders to investigative sites, and strengthen 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, site training, routine and site closure monitoring activities in compliance with protocol, monitoring plans, applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie SOPs, and quality standards to ensure safety and protection of study subjects.
• Customize site engagement strategies for assigned studies; gather local/site insights and use CRM tools to report/track progress and measure strategy impact.
• Connect study protocol, scientific principles, and clinical trial requirements to day-to-day execution; evaluate and ensure effective recruitment and retention techniques based on the patient disease journey.
• Develop knowledge of therapeutic area, asset, and clinical landscape/patient journey to enable successful patient recruitment and protocol compliance.
• Mentor and train less experienced CRAs; may participate in global/local task forces and initiatives; responsible for activities as assigned by manager.
• Conduct continuous risk assessment and collaborate with Central Monitoring to detect early study performance or patient safety issues; resolve site risk signals and implement preventative/corrective action plans with a customer-centric approach.
• Identify, evaluate, and recommend new/potential investigators/sites through networking or internal requests; ensure data quality, timely submission, and safety event reporting; maintain audit and regulatory inspection readiness; manage investigator payments per contract obligations.

Requirements

• 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.
• Familiarity with risk-based monitoring approaches, including onsite and offsite monitoring.
• Knowledge of therapeutic area indications preferred, with 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; ability to work effectively in a dynamic environment with competing priorities 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.