高级临床研究助理（东海岸）
Senior Clinical Research Associate (East Coast)
医学在这里不断前进。你也将如此。
临床试验、安全性研究和审计使安全且创新的以药物为核心的医疗成为可能。作为Ergomed集团的一部分，你帮助患者受益，让他们体验更多生命中的重要时刻。生物制药公司是我们的客户。患者是我们存在的意义。
Ergomed集团汇集了Ergomed CRO、PrimeVigilance、Prudentia和ADAMAS Consulting，帮助生物制药公司开发、交付并保障肿瘤学、罕见病及其他复杂医学领域的疗法。在集团内部，我们的团队将临床试验、安全系统和质量数据所产生的信号转化为洞察力，帮助为全球患者带来更安全的治疗方案。
指导我们工作的科学和分析工作要求很高。而这就是我们的强项。然而，真正定义我们的，是我们如何协作。跨越国家、文化和时区，我们以善意、好奇心和共同的目标感投入到真正重要的工作中。这里欢迎各种想法。我们期待成长。每个人都有机会真正改变患者的生活。
无论你处于职业生涯的早期还是拥有数十年的经验，我们都希望你因你的工作和你的身份而被重视。如果这听起来就是你一直在寻找的地方，我们很期待收到你的来信。
- 执行现场或远程的前期研究、启动、中期和结题监查访问活动，确保研究现场的设施和人员持续符合研究要求
- 确定研究者并验证研究者是否具备足够的资质、资源、设施、设备和人员，在整个研究期间能够开展临床研究
- 必要时对研究现场工作人员进行培训
- 在适用的情况下，协助准备监管和/或伦理委员会提交材料
- 参与新员工的指导/培训以及共同监查访问，以评估初级员工的表现
- 生命科学相关专业本科/大学学位，或同等教育、培训和经验组合
- 丰富的2/3期临床试验现场监查经验，最好有肿瘤学或罕见病复杂试验的经验
- 英语熟练
- 能够规划、多任务处理并在动态团队环境中工作
- 沟通、协作和解决问题的能力
- 能够在国内出差
查看英文原文
Medicine moves forward here. So will you.
Clinical trials, safety studies, and audits make safe and innovative pharmaceutical-led care possible. As part of Ergomed Group, you help patients benefit so they experience more of life’s meaningful moments. Biopharmaceutical companies are our clients. Patients are our purpose.
Ergomed Group brings together Ergomed CRO, PrimeVigilance, Prudentia, and ADAMAS Consulting to help biopharmaceutical companies develop, deliver and safeguard therapies in oncology, rare disease and other complex areas of medicine. Across the Group, our teams turn the signals that clinical trials, safety systems and quality data generate into insight that helps bring safer treatments to patients around the world.
The science and analysis that guides our work is demanding. And this is where we excel. What defines us, though, is how we work together. Across countries, cultures and time zones, we bring kindness, curiosity and a shared sense of purpose to work that genuinely matters. Ideas are welcome here. Growth is expected. And every person has room to make a real difference to patients' lives.
Whether you are early in your career or bringing decades of experience, we want you to feel valued for what you do and for who you are. If that sounds like the place you have been looking for, we would love to hear from you.
- Performs on-site or remote Pre-Study, Initiation, Interim, and Close-Out monitoring visit activities to ensure that facilities and staff at the investigational site continue to be adequate for the conduct of the study
- Identifies the investigators and verifies that the investigator has adequate qualifications, resources, facilities, equipment and staff to conduct the clinical study throughout the study period.
- Trains investigational site staff as necessary
- When applicable, supports preparation of regulatory and / or EC submissions
- Participates in mentoring/training of new staff as well as performing co-monitoring visits, to assess junior staff performance.
- College/University degree in Life Sciences or an equivalent combination of education, training & experience
- Extensive on-site monitoring experience in phase 2/3 trials, ideally with experience of complex trials in oncology or rare disease
- Full working proficiency in English
- Ability to plan, multitask and work in a dynamic team environment
- Communication, collaboration, and problem-solving skills
- Ability to travel nationally
When you join Ergomed Group, you make a difference by helping to bring safe and effective pharmaceutical treatment to patients around the world. You’ll join a passionate and collaborative team of experts in clinical research, pharmacovigilance, and quality consulting.
We are diverse in many ways, yet our values unite us. Our values are how we work, not words on a wall. If they sound like you, you will feel at home here.
· Quality: we hold ourselves to the standard patients deserve.
- Integrity and trust: we do the right thing, especially when it is hard.
- Drive and passion: we care about the outcome, because someone is waiting on it.
- Agility and responsiveness: we move quickly, because patients cannot wait.
- Belonging: everyone is welcome, and every voice counts.
- Collaborative partnerships: we go further by going together.
We look forward to welcoming your application.