Clinical Research Associate I - Oncology- WA-Remote
AbbVie
- Remote job
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. Partners with 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: Primary point of contact for the investigative site, providing contextual information on the clinical trials, connecting stakeholders to investigative sites and strengthening AbbVie’s positioning. Aligns, trains and motivates the site staff and principal investigator under supervision on the goals of the clinical trial program, protocol and patient treatment principles, ensuring a trusted partnership. Conducts site evaluation, site training, routine and site closure monitoring activities under supervision, in compliance with the protocol and monitoring plans and applicable regulations, Good Clinical Practice (GCP) and other quality standards. Customizes site engagement strategy for assigned studies under supervision, gathering local/site insights and utilizing tools such as the Customer Relationship Management (CRM) tool to report, track progress and measure impact. Connects study protocol, scientific principles and clinical trial requirements to day-to-day execution activities, ensuring effective recruitment and retention plans and knowledge of therapeutic area, asset and clinical landscape. Responsible for continuous risk assessment, collaborating with the Central Monitoring team to detect early study performance or patient safety issues, resolving site risk signals while ensuring robust understanding of site processes. Ensures preventative and corrective actions are in place to mitigate risk and promote compliance using a customer-centric approach. Identifies, evaluates and recommends new investigators/sites under supervision and support from experienced CRAs. Ensures quality of data submitted from study sites, timely submission of data, appropriate reporting and follow-up for all safety events. Ensures audit and regulatory inspection readiness at assigned clinical sites at all times and manages investigator payments as per contract obligations. Qualifications: Appropriate tertiary qualification in health-related disciplines (Medical, Scientific, Nursing) preferred or equivalent work experience. Clinically related experience, preferably in clinical research coordinating or data management. Knowledge of therapeutic area indications is preferred and ability to understand and apply scientific concepts related to clinical trials. Knowledge of local regulatory and legal requirements, ICH/GCP Guidelines and applicable policies. Ability to collaborate cross-functionally, plan and organize effectively in dynamic environments. Leverages technology and resources to provide customer-centric support, applying critical thinking and good judgement to address clinical site issues. Strong interpersonal skills with written, verbal, active listening and presentation skills; establishes and leverages site relationships through engagement, motivation and training. Acts with integrity in accordance with AbbVie code of business conduct and leadership values; self-motivated and focused on timely, quality outcomes in a fast-paced environment. Additional Information: The compensation range described is the range of possible base pay AbbVie will pay for this role at the time of posting based on the job grade. Individual compensation will vary by geographic location and may be modified in the future. We offer a comprehensive benefits package 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. No amount of pay is considered wages or compensation until earned, vested and determinable. 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 AbbVie
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