Clinical Research Associate II

Job Description

This position will be field based in Central Florida. Advance Abb Vie'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.

Partner with investigator and site staff for meaningful and effective engagements positioning Abb Vie 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.

• Serve as the primary point of contact for the investigative site, providing contextual information on the clinical trials and strengthening Abb Vie’s positioning.
• Align, train and motivate site staff and principal investigator on the goals of the clinical trial program, protocol and patient treatment principles, ensuring a trusted partnership.
• Conduct site evaluation, training, routine monitoring, and site closure monitoring activities in compliance with protocol, monitoring plans, applicable regulations, GCP, ICH guidelines, Abb Vie SOPs and quality standards.
• Customize site engagement strategy for assigned studies, gather local/site insights, and use site engagement tools such as CRM to report, track progress and measure impact of the strategy.
• Translate the study protocol, scientific principles and clinical trial requirements to day‑to‑day clinical trial execution activities; evaluate recruitment and retention techniques/plans based on patient disease journey; develop knowledge of therapeutic area and clinical landscape to enable successful patient recruitment and protocol compliance.
• Mentor and train less experienced CRAs; contribute to global/local task forces and initiatives; undertake other activities as assigned by manager.
• Perform continuous risk assessment proactively and collaborate with Central Monitoring team to detect early study performance or patient safety issues.
• Think critically to resolve site risk signals; drive study execution; ensure preventive and corrective action plans are implemented to mitigate risk and promote compliance.
• Identify, evaluate and recommend new or potential investigators/sites on an ongoing basis; assist in placement of planned clinical studies with qualified investigators.
• Ensure data quality from study sites, timely submission of data and reporting of all safety events; maintain audit and regulatory inspection readiness; manage investigator payments as per contract obligations.

• Appropriate tertiary qualification in health‑related disciplines (medical, scientific, nursing) preferred.
• Minimum of 1 year of clinically related experience, including 6 months of clinical research monitoring of investigational drug or device trials; familiarity with risk‑based monitoring, onsite and offsite monitoring.
• Knowledge of therapeutic area indications preferred; ability to understand and apply scientific concepts to conduct of clinical trials.
• Advanced knowledge of local regulatory, legal requirements, ICH/GCP Guidelines and applicable policies.
• Strong cross‑functional collaboration skills with internal and external stakeholders.
• Strong planning and organizational skills, 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 skills, including written, verbal, active listening and presentation skills; ability to establish trusted partnerships through engagement, motivation and training.
• Ability to apply critical thinking skills and good judgment to address clinical site issues.
• Acts with integrity in accordance with Abb Vie code of business conduct and leadership values; self‑motivated and focused on delivering timely, quality outcomes in a fast‑paced environment.

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for…