Clinical Research Associate II
AbbVie
About AbbVie AbbVie’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 including immunology, oncology and neuroscience, and products and services in our Allergan Aesthetics portfolio. Job Description 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. Partner 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 Serve as the primary point of contact for the investigative site, providing contextual information on clinical trials, connecting stakeholders to sites and strengthening AbbVie’s positioning. Align, train and motivate site staff and principal investigators on the goals of the clinical trial program, protocol and patient treatment principles for the trial ensuring a trusted partnership. Conduct site evaluation, training, routine and closure monitoring activities in compliance with the protocol, monitoring plans, Good Clinical Practice (GCP), ICH Guidelines, AbbVie SOPs and quality standards, ensuring safety and protection of study subjects. Apply advanced understanding of site engagement to customize engagement strategies for assigned studies, gather local/site insights and utilize tools such as the Customer Relationship Management (CRM) tool to track progress and measure impact. Translate study protocol, scientific principles and clinical trial requirements into day-to-day execution activities, evaluate and ensure effective recruitment and retention techniques/plans based on the patient disease journey, and develop knowledge of therapeutic area, asset and clinical landscape. Mentor and train less experienced CRAs on various aspects of work and provide input into their development; may participate in global/local task forces and initiatives. Conduct continuous risk assessment proactively with the Central Monitoring team, monitoring activities to detect early overall study performance or patient safety issues. Resolve site risk signals, ensuring preventative and corrective action plans are implemented and compliance is promoted using a customer‑centric approach. Identify, evaluate and recommend new or potential investigators/sites on an ongoing basis through networking or AbbVie requests. Ensure quality of data submitted from study sites, timely submission of data, appropriate reporting and follow‑up for all safety events; maintain audit and regulatory inspection readiness and manage investigator payments per contract obligations. Qualifications Appropriate tertiary qualification in a health‑related discipline (Medical, Scientific, Nursing) preferred. Minimum of 1 year of clinically related experience, with at least 6 months in 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 related to clinical trials. 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, able 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 to establish and maintain site relationships and trusted partnerships. Ability to use functional expertise with appropriate guidance, apply critical thinking and good judgement to address clinical site issues. Acts with integrity in accordance with AbbVie’s code of business conduct and leadership values; self‑motivated and focused on delivering timely, quality outcomes in a fast‑paced environment. Compensation and Benefits Compensation range based on job grade and geographic location; may change in future. Comprehensive benefits package including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k). Eligible for short‑term incentive programs. Equal Opportunity Employer AbbVie is an equal‑opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only – learn more at US & Puerto Rico applicants seeking a reasonable accommodation – learn more at #J-18808-Ljbffr AbbVie
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