临床研究运营专员
Clinical Study Operations Associate
Beacon Biosignals正在将精准医学应用于大脑领域,从临床开发到临床护理。对于生命科学合作伙伴,我们提供领先的居家脑电图(EEG)平台,用于新型治疗药物的临床开发,针对神经系统、精神疾病和睡眠障碍。我们的诊断业务正在构建最全面的居家诊断平台,结合脑电图和心肺信号,为睡眠和中枢神经系统疾病提供可报销的评估服务。我们正在改变患者被诊断和治疗的方式,无论其疾病如何影响大脑生理。
我们正在寻找一名临床试验运营专员加入我们的团队,共同实现让脑监测变得易于获取、可解读和可操作的使命。在此职位中,您将与临床研究机构、项目团队和内部利益相关者合作,支持Beacon设备在临床研究中的部署。该职位专注于研究启动、站点管理和实时研究监控,确保最高质量标准并符合监管要求。
该职位为远程办公,可在美国太平洋时间或山地时间区内的任何地方工作,可能需要最多5%的出差。Beacon完善的异步工作实践确保了卓越的远程办公体验,但我们也在波士顿、纽约和巴黎设有线下办公室。
成功的表现包括:
- 与项目团队合作,支持研究启动活动。
- 作为临床站点的主要联系人,确保顺畅运作和清晰沟通。
- 为研究站点提供Beacon设备和研究方案的培训,确保设备正确使用和数据收集。
- 监督项目进展,确保遵守时间表、方案和质量标准。
- 遵守良好临床实践(GCP)、国际协调会议(ICH)指南和监管标准。
- 及时处理运营问题,通过Zendesk和Asana等工具进行升级以解决。
- 从研究站点获取可操作的反馈,以改进设备和流程。
您将带来的能力:
- 2-4年以上临床项目管理或临床运营相关工作经验。
- 强大的组织和项目管理能力,能够有效管理多项职责。
- 出色的书面和口头沟通能力
查看英文原文
Beacon Biosignals is transforming precision medicine for the brain, from clinical development to clinical care. For Life Sciences partners, we offer the leading at-home EEG platform for clinical development of novel therapeutics for neurological, psychiatric, and sleep disorders. Our Diagnostics business is building the most comprehensive at-home platform for precision diagnostics, combining EEG and cardiopulmonary signals to deliver reimbursable assessments for sleep and central nervous system disorders. Together, we're changing the way patients are diagnosed and treated for any disorder that affects brain physiology.
We are seeking a Clinical Trial Operations Associate to join us in our mission to make brain monitoring easily accessible, interpretable, and actionable. In this role, you will collaborate with clinical research sites, project teams, and internal stakeholders to support the deployment of Beacon’s devices in clinical studies. This role focuses on study startup, site management, and live-study monitoring, ensuring the highest quality standards and compliance with regulatory requirements.
This role is fully remote anywhere in the Pacific or Mountain Timezones in the U.S. and will require up to 5% travel. Beacon's robust asynchronous work practices ensure a first-class remote work experience, but we also have in-person office hubs available located in Boston, New York, and Paris.
What success looks like
- Collaborate with project teams to support study startup activities.
- Act as the primary point of contact for clinical sites, ensuring smooth operations and clear communication.
- Provide training to research sites on the use of Beacon’s devices and study protocols, ensuring proper device usage and data collection.
- Monitor project progress, ensuring adherence to timelines, protocols, and quality standards.
- Maintain compliance with Good Clinical Practice (GCP), International Conference on Harmonization (ICH) guidelines, and regulatory standards.
- Address operational issues promptly, escalating through tools like Zendesk and Asana for resolution.
- Provide actionable feedback from research sites to inform improvements in devices and workflows.
What you will bring
- 2-4+ years of experience in clinical project management or clinical operations roles.
- Strong organizational and project management skills, with the ability to manage multiple responsibilities effectively.
- Excellent written and verbal communication skills in English, additional languages are a bonus.
- Proactive mindset with the ability to identify priorities and anticipate challenges.
- Meticulous attention to detail, ensuring accuracy in data collection and reporting.
- Familiarity with GCP, ICH guidelines, and clinical research regulatory requirements.
- Desire to learn more about analytics, statistics, machine learning, and clinical trials.
The salary range for this role is $65,000 – $85,000. Salary ranges are determined using current market compensation data for this role and adjusted based on experience, skills, and location. The base salary is one component of the total compensation package, which includes equity, PTO, and other benefits.
At Beacon, we've found that cultural and scientific impact is driven most by those that lead by example. As such, we're always seeking new contributors whose work demonstrates an avid curiosity, a bias towards simplicity, an eye for composability, a self-service mindset, and - most of all - a deep empathy towards colleagues, stakeholders, users, and patients. We believe a diverse team builds more robust systems and achieves higher impact.