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Clinical Research Associate II - Oncology (California)

BioSpace

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 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 Considered the primary point of contact for the investigative site. Provide contextual information on the clinical trials, connect stakeholders to the investigative sites and strengthen AbbVie's positioning. Align, train and motivate site staff and principal investigator 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 monitoring and site closure activities with compliance to protocol, monitoring plans, applicable regulations and Good Clinical Practices. Apply site engagement strategy customized for assigned studies, gather local/site insights, and use tools such as the Customer Relationship Management tool to report, track progress and measure impact. Connect study protocol, scientific principles and clinical trial requirements to day‑to‑day execution activities. Evaluate and ensure effective recruitment and retention techniques/plans based on patient disease journey. Mentor and train less experienced CRAs, provide input into their development, participate in task forces and initiatives, and be responsible for activities assigned by manager. Conduct continuous risk assessment and, together with the Central Monitoring team, monitor site activities to detect early study performance or patient safety issues. Resolve site risk signals with a robust understanding of site processes, implementing preventative and corrective actions as needed. Identify, evaluate and recommend new or potential investigators/sites on an ongoing basis. Ensure quality of data submitted from sites, timely submission of safety events, audit and regulatory inspection readiness, and manage investigator payments as per 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. Experience with risk‑based monitoring approach, onsite and offsite monitoring. Knowledge of therapeutic area indications and ability to apply scientific concepts to clinical trial conduct. Knowledge of local regulatory and legal requirements, ICH/GCP Guidelines and applicable policies. Strong cross‑functional collaboration skills. Strong planning and organizational skills and ability to work in a dynamic environment with competing projects and deadlines. 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; ability to establish site relationships and trusted partnerships. Good judgement, integrity and self‑motivation to deliver timely quality outcomes in a fast‑paced environment. Benefits Comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k). Eligibility to participate in short‑term incentive programs. Compensation range: The compensation range described below is the range of possible base pay for this role. Individual compensation will depend on many factors and may be modified in the future. 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, visit #J-18808-Ljbffr BioSpace

Vacancy posted 2 days ago
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