临床研究专员II
Clinical Research Associate II
关于艾伯维
艾伯维的使命是发现并提供创新药物和解决方案，以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产生重大影响，包括免疫学、肿瘤学和神经科学——以及我们Allergan Aesthetics产品组合中的产品和服务。有关艾伯维的更多信息，请访问我们的网站 www.abbvie.com。关注我们在 LinkedIn、Facebook、Instagram、X 和 YouTube 上的账号。
为使艾伯维成为世界级的研发组织，该职位需预见并主动解决临床现场相关的问题，同时发起、建议并沟通纠正措施，确保SMM交付物在方案层面的成功执行，涉及研究启动、执行和结束。
- 监督与艾伯维临床研究相关的临床研究现场活动，以确保方案成功执行。确保遵守联邦法规和适用的当地法规、良好临床实践（GCP）、ICH指南、艾伯维标准操作规程（SOP）和监测计划，以及进行临床研究的质量标准。
- 根据适用法规、良好临床实践（GCP）、ICH指南和艾伯维标准操作规程（SOP）及业务流程，开展I-IV期研究的现场资格评估、启动、中期监测和研究结束访问。
- 综合管理没有直接管辖权的现场人员的整体活动，并激励/影响他们达成研究目标。积极管理现场，确保在需要时制定行动计划以确保合规性。确保指定临床现场的监管检查准备就绪。
- 确保从研究现场提交的数据质量，并保证数据及时提交，包括所有安全事件的适当报告和跟进。
- 通过遵守研究监测计划、艾伯维SOP、ICH指南和适用法规，确保研究受试者的安全和保护。
- 与相关项目团队成员合作，对研究现场人员进行方案和适用监管要求的培训。
- 根据已签署的合同义务管理研究者付款。与相关方协商研究者/医院协议。维护并完成自己的费用报销。
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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.
To enable AbbVie’ s emergence as a world class R&D organization, the position anticipates and proactively solves study-related clinical site issues as they occur and initiates, recommends and communicates corrective action ensuring successful protocol level execution of SMM deliverables involving start-up, execution, and close-out of studies.
· Monitors activities conducted by clinical investigative sites as they relate to AbbVie clinical studies to ensure successful execution of the protocol. Ensures adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), Monitoring Plans, and to quality standards in conducting clinical research.
· Conducts site qualification, initiation, interim monitoring and study closeout visits for Phase 1-4 studies in accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, and AbbVie Standard Operating Procedures (SOPs) and business processes.
· Overviews the overall activities of site personnel over whom there is no direct authority and motivates/influences them to meet study objectives. proactively manages the site and ensures action plans are put into place as needed to ensure compliance. Ensures regulatory inspection readiness at assigned clinical sites.
· Ensures quality of data submitted from study sites and assures timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel.
· Ensures safety and protection of study subjects through compliance with the study monitoring plan, AbbVie SOPs, ICH Guidelines, and applicable regulations.
· Trains study site personnel on the protocol and applicable regulatory requirements in collaboration with pertinent project team members.
· Manages investigator payments as per executed contract obligations. Negotiates investigator/ hospital agreements with stakeholders. Maintain and complete own expense reports as per local and applicable guidelines.
· Identifies, evaluates and recommends new/potential investigators/sites on an on going basis. Potential sites may be identified through networking or internal AbbVie requests to assist in the placement of planned clinical studies with qualified investigators.
- Bachelor’s degree in a scientific or related field.
- Minimum of 1 year of clinically-related experience, of which a period of 6 months is preferable in clinical research monitoring. Experience in on-site monitoring of investigational drug or device trials is required.
- Fluent in English, both written and verbal.
- Current in-depth knowledge and understanding of appropriate 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 regulations.
- Strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines. Ability to work, understand and follow work processes within the assigned function.
- Strong analytical and conceptual capabilities, interpersonal skills, and ability to communicate with clarity. Ability to address study related clinical site issues with appropriate guidance and initiates and communicate corrective action as indicated. Ability to use functional expertise and exercise good judgment.
- Demonstrated business ethics and integrity.
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.
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