临床研究助理
Clinical Research Associate
关于AbbVie
AbbVie的使命是发现并提供创新药物和解决方案，解决当前严重的健康问题，并应对未来的医疗挑战。我们致力于在多个关键治疗领域，包括免疫学、肿瘤学和神经科学产生显著影响，并通过Allergan Aesthetics产品组合中的产品和服务实现这一目标。如需了解有关AbbVie的更多信息，请访问我们的网站www.abbvie.com。请在LinkedIn、Facebook、Instagram、X和YouTube上关注@abbvie。
AbbVie正在寻找一名临床研究助理（CRA）以支持比利时的临床研究。该职位与研究人员和现场团队合作，促进有效研究交付、数据质量、合规性以及积极的现场体验。
主要职责
· 作为指定研究现场的主要联系人，提供相关研究信息并与内部利益相关者协调。
· 与研究人员和现场工作人员建立有效的合作关系，并支持他们理解研究目标、方案和患者治疗原则。
· 按照方案、监测计划、适用法规、GCP、ICH指南、AbbVie标准操作程序和质量标准，进行现场评估、启动、常规监测和结题活动。
· 在整个临床试验过程中支持研究参与者的安全和保护。
· 根据研究需求和当地现场洞察，制定和调整现场参与策略，使用可用工具跟踪进度并衡量影响。
· 运用对方案、科学原理、治疗领域和患者旅程的知识，支持招募、保留和方案依从性。
· 进行持续的风险评估，并与中央监测团队合作，识别潜在的研究表现或患者安全问题。
· 调查现场风险信号，并在需要时确保实施适当的预防和纠正措施计划。
· 确保现场人员及时提交数据和安全信息，同时保持审计和检查准备就绪。
· 识别并推荐潜在的研究人员和现场，参与指定的项目，并通过指导和培训支持经验较少的CRA的发展。
- 医学、生命科学、护理或相关科学领域的学位或同等资格。
- 至少一年的相关工作经验。
查看英文原文
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.
AbbVie is looking for a Clinical Research Associate (CRA) to support clinical studies in Belgium. The role partners with investigators and site teams to promote effective study delivery, data quality, compliance, and a positive site experience.
Key Responsibilities
· Serve as the primary point of contact for assigned investigative sites, providing relevant study information and coordinating with internal stakeholders.
· Build effective working relationships with investigators and site staff, and support their understanding of the study objectives, protocol, and patient treatment principles.
· Conduct site evaluation, initiation, routine monitoring, and close-out activities in accordance with the protocol, monitoring plans, applicable regulations, GCP, ICH Guidelines, AbbVie SOPs, and quality standards.
· Support the safety and protection of study participants throughout the clinical trial.
· Develop and adapt site engagement strategies based on study requirements and local site insights, using available tools to track progress and measure impact.
· Apply knowledge of the protocol, scientific principles, therapeutic area, and patient journey to support recruitment, retention, and protocol compliance.
· Conduct ongoing risk assessments and collaborate with the Central Monitoring team to identify potential study performance or patient safety issues.
· Investigate site risk signals and ensure appropriate preventive and corrective action plans are implemented when required.
· Ensure the quality and timely submission of data and safety information by site personnel, while maintaining audit and inspection readiness.
· Identify and recommend potential investigators and sites, contribute to assigned initiatives, and support the development of less experienced CRAs through mentoring and training.
- Degree or equivalent qualification in a health-related discipline, such as Medicine, Life Sciences, Nursing, or a related scientific field.
- At least one year of clinically related experience, including a minimum of six months of experience in clinical research monitoring of investigational drug or device trials.
- Familiarity with risk-based monitoring approaches, including on-site and remote monitoring.
- Knowledge of relevant therapeutic areas and the ability to apply scientific concepts to clinical trial conduct.
- Knowledge of local regulatory and legal requirements, ICH/GCP Guidelines, and applicable policies.
- Fluency in French, Dutch, and English is required.
- Strong collaboration, communication, active listening, and presentation skills, with the ability to build effective relationships with investigators and site teams.
- Strong planning and organizational skills, with the ability to manage competing priorities and deadlines.
- Ability to use technology, monitoring tools, and available resources to support site engagement and study execution.
- Ability to apply sound judgment, critical thinking, and functional expertise when addressing clinical site issues.
- Self-motivated and quality-focused, with a commitment to integrity and compliance with AbbVie’s Code of Business Conduct and Leadership Values.
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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