临床研究专员II
Clinical Research Associate II
医学在这里不断前进。你也将如此。
Ergomed 是一家专注于罕见疾病和特定肿瘤适应症的临床研究专业机构。我们专注于最复杂的试验，这些研究中，经验、判断力和严谨的运营责任能产生最大的影响。我们与中小型生物科技公司合作，推动有前景的疗法进入早期阶段开发，使它们更快地到达患者手中。
我们有意选择复杂的工作。罕见疾病和肿瘤试验具有真正的运营风险，而我们的员工是降低风险的专家，在保护时间表、数据质量和现场及患者的体验的同时，确保一切顺利进行。这是一项要求高且有意义的工作，这里没有人会忘记患者不能等待。
这就是为什么文化对我们而言和能力一样重要。我们建立了一个协作、国际化的团队，人们分享想法、发展职业生涯，并被信任在早期就承担起责任。我们拥有遍布北美、南美、欧洲、亚洲和澳大利亚的同事，我们重视团队合作、灵活性和对工作与生活平衡的真实承诺，因为优秀的科学来自感到被支持的人。
如果你希望从事有目标的工作，拥有迅速产生影响的敏捷性，以及一个既关心工作本身也关心背后人的团队，我们期待你的加入。
- 需要全国范围出差
- 执行现场或远程的准备期、启动期、中期和结题监查访问活动，以确保研究现场的设施和工作人员持续符合研究开展的要求
- 确定研究者并验证研究者是否具备足够的资质、资源、设施、设备和人员来在整个研究期间开展临床研究
- 必要时培训研究现场工作人员
- 在适用的情况下，协助准备监管和/或伦理委员会提交材料
- 生命科学相关专业的大学/学位，或同等教育、培训和经验组合
- 丰富的2/3期试验现场监查经验，最好有复杂试验（如肿瘤/罕见疾病）的经验
- 英语流利
- 能够计划、多任务处理并在动态团队环境中工作
- 具备沟通、协作和解决问题的能力
- 能够出差
当你加入 Ergomed 集团，你将通过帮助为全球患者带来安全有效的药物治疗而产生影响。
查看英文原文
Medicine moves forward here. So will you.
Ergomed is a specialist clinical research organization focused on rare disease and select oncology indications. We focus on the most complex trials, the studies where experience, judgement, and rigorous operational accountability make the biggest difference. We partner with small to midsize biotech companies to move promising therapies through early phase development, so they reach the patients sooner.
We choose complex work on purpose. Rare disease and oncology trials carry real operational risk, and our people are experts at reducing it, protecting timelines, data quality and the experience of sites and patients at the same time. It is demanding, meaningful work, and no one here forgets that patients cannot wait.
That is why culture matters to us as much as capability. We have built a collaborative, international team where people share ideas, grow their careers and are trusted to take ownership early. With colleagues across North America, South America, Europe, Asia and Australia, we value teamwork, flexibility and a real commitment to work-life balance, because good science comes from people who feel supported.
If you want work with purpose, the agility to make an impact and a team that cares about the people behind the work as much as the work itself, we would love to hear from you.
- National Travel Required
- 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 conducting the clinical study throughout the study period.
- Trains investigational site staff as necessary
- When applicable, supports preparation of regulatory and / or EC submissions
- 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 such as oncology / 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
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