Senior Clinical Research Associate - Sponsor Dedicated - Oncology Experience Nee
当我们的价值观一致时，我们能达到什么样的目标都没有限制。在 Parexel,我们都有相同的目标 - - 改善世界健康。从临床试验到监管，咨询和市场准入，我们提供的每种临床开发解决方案都是基于某种特殊的东西 - - 我们对所做的事情深厚的信念。无论我们在 Parexal 做什么，我们每个人都有助于开发一种最终有利于患者的治疗方法。我们把工作视为个人，我们以同情感而做并致力于改变.Parexel FSP 正在聘请一名经验丰富的高级 CRA 级别的人加入欧盟大型赞助商之一。该职位负责现场管理，现场监测和指定临床试验研究人员网站的关闭，以确保患者安全和质量进行研究。关于该角色的一些细节 · 根据研究监测计划以及适用的法律，良好临床实践，确保适当开展临床试题。· 从从局部激活到数据库锁定，确保符合相关时间表和质量的交付结果。· 根据需要与研究团队进行互联，促进研究团队成员，供应商和分配的调查地点之间的信息流动。· 监测现场级 AEs 和 SAE 并与药物安全部门合作，并在必要时跟踪调查人员网站，以解决所需的 SAE 报告。· 作为审计行为联系点，推动 CAPA 开发和检查，如有所适用，Parexel 在整个治疗领域支持临床研究，我们拥有长期以来的伙伴关系，拥有庞大的客户群体。我们支持了当今50大最销药物的试验，但同样我们还能够为许多患者的福祉至关重要的一些基层药物开发。你将成为更广泛团队的一个影响力成员。我们在这个角色中寻找什么？对于每个职位来说，我们都在寻找那些有决心和勇气始终把病人幸福放在首位的专业人士。这对我们是以心脏工作。以下是广告中的这一职位特定的一些要求。· 生物科学学士学位或生命科学专业学位如护理，药房，医学背景或等级 · 广泛知识
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When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
Parexel FSP is hiring for an experienced Senior CRA level to join one of a large Sponsor’s in the EU.
This role is responsible for the site management, site monitoring and close-out of assigned clinical trials investigator sites to ensure patient safety and quality study execution
Some specifics about this advertised role
- Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan and applicable prevailing laws, Good Clinical Practices.
- Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through database lock, ensuring relevant timelines and quality deliverables are met.
- Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites.
- Monitor site level AEs and SAEs and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to bring SAE reports required information to resolution.
- Serve as a point of contact for audit conduct, and drive Audit Observation CAPA development and checks, when applicable
Who are Parexel
Parexel supports clinical studies across the full range of therapeutic areas, and we have longstanding partnerships with a vast client base.
We supported the trials of most of today’s top 50 best-selling drugs, but equally we enable more niche drug developments that are critical to the well-being of many patients.
You’ll be an influential member of the wider team.
What we are looking for in this role
For every role, we look for professionals who have the determination and courage always to put patient well-being first.
That to us is working with heart.
Here are a few requirements specific to this advertised role.
- Bachelor’s degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent
- Extensive knowledge of clinical trial methodologies, ICH/GCP, FDA and local country regulations
- Monitoring Experience: Minimum 3.5 years relevant experience in clinical research site monitoring (preferably in Oncology)
- Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases
Originally posted on Himalayas