Clinical Research Associate II- Immunology - Chicago (Remote)
BioSpace, Inc.
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 Purpose: 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 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 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 investigative sites, providing contextual information on clinical trials, connecting stakeholders, and strengthening AbbVie’s positioning. Align, train and motivate site staff and principal investigators on trial program goals, protocol and patient treatment principles to build trusted partnerships. Conduct site evaluations, training, routine, and closure monitoring activities in compliance with protocol, GCP, ICH Guidelines, AbbVie SOPs, and quality standards, ensuring safety and protection of study subjects. Develop advanced understanding of site engagement and customize engagement strategy for assigned studies, gathering local/site insights and using CRM tools to track progress and measure impact. Link study protocol, scientific principles and clinical trial requirements to day-to-day execution, evaluate recruitment and retention techniques, and develop solid knowledge of therapeutic area, asset and clinical landscape to enable successful patient recruitment and protocol compliance. Mentor and train less experienced CRAs, provide input into their development and may participate in global/local task forces and initiatives. Perform continuous risk assessment proactively and collaborate with Central Monitoring to detect early performance or patient safety issues. Use critical thinking to resolve site risk signals, implement preventive and corrective actions, and promote compliance with a customer-centric approach. Identify, evaluate and recommend new/potential investigators/sites on an ongoing basis, utilizing networking or internal AbbVie requests. Ensure quality of data submitted from study sites, timely submission of safety events, audit/readiness, and manage investigator payments per contract obligations. Qualifications Appropriate tertiary qualification in health-related disciplines (Medical, Scientific, Nursing) preferred. Minimum of 1 year of clinically related experience, including at least 6 months of clinical research monitoring of investigational drug or device trials; familiar with risk-based 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. Excellent planning and organizational skills and ability to work effectively in a dynamic environment with competing deadlines. Advanced ability to leverage technology, tools and resources for customer-centrif support based on site health. Strong interpersonal, written, verbal, listening and presentation skills to establish trusted partnerships. Ability to apply critical thinking skills and good judgement to address clinical site issues. Acts with integrity in accordance with AbbVie code of business conduct and leadership values; self-motivated and focused on delivering timely, quality outcomes in a fast-paced environment. Additional Information The compensation range described below is the range of possible base pay compensation that the Company believes in good faith will be paid for this role at the time of this posting, based on the job grade. Individual compensation paid within this range will depend on many factors including geographic location and may ultimately be higher or lower. We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. This job is eligible to participate in our short-term incentive programs. Note: no amount of pay is considered wages or compensation until earned, vested and determined. 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. #J-18808-Ljbffr
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