Company Description
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. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
Job Description
AbbVie is seeking a Clinical Research Associate (CRA) to join our team in Israel. As part of AbbVie’s commitment to being a world-class R&D organization, the Clinical Research Associate plays a key role in ensuring the successful delivery of clinical studies. The position proactively identifies and resolves study-related issues at clinical sites and supports the implementation of appropriate corrective actions throughout the study lifecycle, including site start-up, study conduct, and close-out activities.
עיקרי התפקיד
Monitor activities conducted by clinical investigative sites in support of AbbVie clinical studies to ensure the successful execution of study protocols.
Ensure adherence to federal and applicable local regulations, Good Clinical Practice (GCP), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), monitoring plans, and quality standards for the conduct of clinical research.
Conduct site qualification, initiation, interim monitoring, and study closeout visits for Phase 1–4 studies in accordance with applicable regulations, GCP, ICH Guidelines, AbbVie SOPs, and relevant business processes.
Oversee the activities of site personnel, despite having no direct authority, and motivate and influence them to meet study objectives.
Proactively manage assigned sites and ensure that appropriate action plans are implemented as needed to maintain compliance.
Ensure regulatory inspection readiness at assigned clinical sites.
Ensure the quality of data submitted by study sites and the timely submission of data, including appropriate reporting and follow-up of all safety events by site personnel.
Ensure the safety and protection of study subjects through compliance with the study monitoring plan, AbbVie SOPs, ICH Guidelines, and applicable regulations.
Train study site personnel on the study protocol and applicable regulatory requirements in collaboration with relevant project team members.
Manage investigator payments in accordance with executed contractual obligations.
Negotiate investigator and hospital agreements with relevant stakeholders.
Maintain and complete expense reports in accordance with local and applicable guidelines.
Identify, evaluate, and recommend new and potential investigators and clinical sites on an ongoing basis. Potential sites may be identified through networking or internal AbbVie requests to support the placement of planned clinical studies with qualified investigators.
דרישות
Minimum of 1 to 2 years of experience as a CRA at a pharmaceutical company or CRO. Candidates with approximately 2 years of experience in clinical trials field, particularly within oncology or immunology, can be considered.
Experience conducting on-site monitoring of investigational drug or medical device trials is required.
Current, in-depth knowledge and understanding of relevant therapeutic indications as they relate to the conduct of clinical trials.
Current, in-depth knowledge of regulations governing clinical research, ICH/GCP Guidelines, and applicable local regulations.
Strong planning and organizational skills, with the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines.
Ability to understand and follow work processes within the assigned function.
Strong analytical and conceptual capabilities, interpersonal skills, and the ability to communicate clearly.
Ability to address clinical site issues with appropriate guidance, initiate corrective actions, and communicate them effectively.
Ability to apply functional expertise and exercise sound judgment.
Demonstrated business ethics and integrity.
Additional Information
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 https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
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