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Clinical Research Associate II

BioSpace

About AbbVie AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address future medical challenges. We aim to have a remarkable impact on patients’ lives across immunology, oncology, neuroscience, and the Allergan Aesthetics portfolio. Job Description Advance AbbVie's pipeline by striving for excellence in clinical research, turning science into medicine and leveraging new advanced capabilities to drive industry‑leading performance. Partner with investigators and site staff for meaningful and effective engagement, positioning AbbVie as the choice in clinical trials. Focus on site clinical research that ensures appropriate conduct of trials while driving improvement in data integrity, compliance, overall study performance, and customer experience. Responsibilities Primary point of contact for the investigative site; provide contextual information on clinical trials, connect stakeholders, and strengthen AbbVie's positioning. Align, train, and motivate site staff and principal investigators on trial goals, protocol, and patient treatment principles, fostering a trusted partnership. Conduct site evaluation, training, routine monitoring, and site closure activities in compliance with protocol, monitoring plans, GCP, ICH guidelines, AbbVie SOPs, and quality standards. Use advanced site engagement strategy, gather local insights, and utilize CRM tools to report progress and measure impact. Translate study protocol and scientific principles into day‑to‑day trial execution; ensure effective recruitment and retention and understand therapeutic area and patient journey. Mentor and train less experienced CRAs; provide input into their development; participate in task forces and initiatives as assigned. Continuously assess risk and collaborate with the Central Monitoring team to detect study performance or patient safety issues; implement corrective actions. Able to think critically to resolve site risk signals and drive study execution, with a customer‑centric approach. Identify, evaluate, and recommend new investigators or sites on an ongoing basis; support placement of qualified investigators. Ensure quality data submission, timely reporting of safety events, regulatory inspection readiness, and manage investigator payments per contract. Qualifications Appropriate tertiary qualification in health‑related disciplines (Medical, Scientific, Nursing). Minimum of 1 year 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 therapeutic area indications and ability to 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, planning, and organizational skills to manage dynamic projects. Proficiency in technology, tools, and resources to provide customer‑centric support. Excellent interpersonal, written, verbal, active listening and presentation skills; ability to establish and maintain trusted site relationships. Critical thinking and good judgment to address clinical site issues. Integrity in accordance with AbbVie code of conduct and leadership values; self‑motivated and results‑focused. Compensation and Benefits Competitive base pay commensurate with role and location; detailed compensation may vary. Comprehensive benefits including paid time off (vacation, holidays, sick), medical, dental, vision insurance, and 401(k) eligibility. Eligibility to participate in short‑term incentive programs. Equal Opportunity Employer AbbVie is an equal opportunity employer and is committed to operating with integrity and serving our community. Equal Opportunity Employer / Veterans / Disabled. For more information on equal‑employment‑opportunity obligations, visit US & Puerto Rico applicants seeking a reasonable accommodation can learn more at #J-18808-Ljbffr BioSpace

Vacancy posted 2 days ago
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