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Clinical Research Associate II - Neuro & Immunology (Remote US - Multiple Openings)

Initial Therapeutics, Inc.

Company Description 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, as well as products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube. Job Description We are hiring in Chicago, Southern California & NY (Northeast). 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 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 the 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, and site‑closure monitoring activities in compliance with the protocol and monitoring plans, applicable regulations, Good Clinical Practice (GCP) guidelines, ICH guidelines, AbbVie SOPs, and quality standards, ensuring safety and protection of study subjects. Maintain an advanced understanding of site engagement and customize engagement strategy for each assigned study. Gather local/site insights and utilize the Customer Relationship Management (CRM) tool to report, track progress, and measure impact. Translate the 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. Develop solid knowledge of the therapeutic area, asset, and clinical landscape to enable successful patient recruitment and overall protocol compliance. Mentor and train less experienced CRAs on various aspects of work, providing input into their development. Participate in global/local task forces and initiatives as assigned by the manager. Perform continuous risk assessment proactively, collaborating with the Central Monitoring team to detect early study performance or patient safety issues at clinical sites. Use critical thinking to resolve site risk signals, ensuring robust understanding of site processes to drive study execution. Implement preventative and corrective actions as needed to mitigate risk and promote compliance with a customer‑centric approach. Identify, evaluate, and recommend new or potential investigators/sites on an ongoing basis. Potential sites may be identified through networking or internal AbbVie requests to support planned studies with qualified investigators. Ensure data quality from study sites, timely submission of data, and appropriate reporting and follow‑up for all safety events. Maintain audit and regulatory inspection readiness at all times. Manage investigator payments per executed contract obligations. Qualifications Appropriate tertiary qualification in health‑related disciplines (medical, scientific, nursing) preferred. Minimum of 1 year of clinically related experience, including 6 months in clinical research monitoring of investigational drug or device trials. Familiarity with risk‑based monitoring, onsite, and offsite monitoring. Knowledge of relevant therapeutic area indications preferred, with the ability to understand and apply scientific concepts as they relate to clinical trial conduct. Advanced knowledge of local regulatory and legal requirements, ICH/GCP guidelines, and applicable policies. Strong cross‑functional collaboration skills with internal and external stakeholders. Strong planning and organizational skills, capable of working effectively in a dynamic environment with competing projects and deadlines. Proficient in leveraging technology, tools, and resources to provide customer‑centric support based on site health. Excellent interpersonal, written, verbal, active‑listening, and presentation skills, with the ability to establish and leverage site relationships and trusted partnerships through engagement, motivation, and training. Ability to use functional expertise with appropriate guidance, leveraging critical thinking and good judgment to address clinical site issues. Act with integrity according to AbbVie's code of business conduct and leadership values. Self‑motivated and focused on delivering timely and high‑quality outcomes in a fast‑paced environment. Additional Information The compensation range described below reflects the range of possible base pay compensation that AbbVie believes in good faith it will pay for this role at the time of posting based on the job grade. Individual compensation paid within this range will depend on many factors including geographic location. This range may be modified in the future. We offer a comprehensive benefits package including paid time off (vacation, holidays, sick), medical/dental/vision insurance, and a 401(k) to eligible employees. This job is eligible to participate in our short‑term incentive programs. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employer remain in the Company’s sole discretion until paid and may be modified at the Company’s discretion, consistent with applicable law. Equal Opportunity Statement 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 - to learn more, visit US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: #J-18808-Ljbffr

Vacancy posted 4 days ago
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