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

ICompany Description

Abb Vie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio.

The CRA II advances Abb Vie's pipeline by striving for excellence in clinical research, turning science into medicine for patients, and leveraging advanced capabilities to drive industry-leading performance. The CRA II partners with investigators and site staff to build meaningful, effective engagements that position Abb Vie as the sponsor of choice in clinical trials. The role focuses on site clinical research by ensuring proper trial conduct, while continually working to improve data integrity, compliance, overall study performance, and the customer experience.

• Considered as the primary point of contact for the investigative site.
• Aligns, trains and motivates the site staff and principal investigator on the goals of the clinical trial program.
• Conducts site evaluation, training, routine, and site closure monitoring activities in compliance with applicable regulations.
• Advanced understanding of site engagement and ability to customize site engagement strategy for assigned study (ies).
• Advanced level of competency connecting the study protocol, scientific principles and clinical trial requirements to day-to-day execution activities.
• Possesses experienced level of competency to mentor and train less experienced CRAs on various aspects of work and provides input into their development.
• May participate in global/local task forces and initiatives. Responsible for activities as assigned by manager.
• Responsible for continuous risk-assessment proactively, and in collaboration with Central Monitoring team, monitor activities conducted by clinical sites to detect early overall study performance or patient safety issues.
• Advanced ability to think critically to resolve site risk signals while having robust understanding of site processes to drive study execution.
• Identifies, evaluates and recommends new/potential investigators/sites on an on going basis.
• Ensures quality of data submitted from study sites and assures timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel.
• Ensures audit and regulatory inspection readiness at assigned clinical site at all times.
• Manages investigator payments as per executed contract obligations, as applicable.

• Minimum of 1 year of clinically related experience, of which a period of 6 months is required 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) preferred.
• Knowledge of appropriate therapeutic area indications (oncology) is preferred.
• Experience as a study coordinator.

• Advanced knowledge on existing and emerging 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 and efficiently in a dynamic environment with competing projects and deadlines.
• Advanced ability to leverage technology, tools and resources to provide customer centric support based on the health of the site.
• Strong interpersonal skills with excellent written, verbal, active listening and presentation skills, with ability to establish and leverage 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 judgement to address clinical site issues.
• Acts with integrity in accordance with Abb Vie code of business…