临床研究助理1
Clinical Research Associate 1
作为全球最大的 FSP 组织，拥有90多个赞助商合作伙伴关系，我们提供稳定性，职业发展和协作环境，你的工作有助于开发有益于世界各地患者的治疗。作为英国本土的 ICON In Vitro Diagnostics CRA,你将参与我们的临床试验运营功能，工作在热情，动态团队中。这是从基于实验室的设置转向 CRA 角色，嵌入到蓝筹临床诊断项目中，你将加入你的独特机会。你将要做什么：你的角色将包括高标准的临床试验监测工作，与团队和利益相关者密切合作。主要责任包括：·确保研究按照研究协议，操作程序和良好的临床实践进行；·验证产品性能要求；·提供关键规范提交数据；定义调查产品的功能和临床效用性。·提供关键监管提交的数据 ·了解和实施联邦法规，帮助推出 SOP 以确保研究遵守 FDA 规定，GCP,IVD 指令和客户政策。你的个人资料：你将从实验室背景中获得相关 In Vitro 诊断经验，以及以下资格和技能。所需的资格和经验：·医学，科学或相等领域的大学学位 · 临床试验过程中的实践知识 · 英语书面和口头沟通能力；· 愿意从英国 （有时国际）的基地出境，根据其职位所在的国家工作的合法权利而获得 ICON 的工作。ICON 提供了一个具有竞争力的全面奖励方案，旨在支持你的健康，福祉和职业发展。
查看英文原文
CRA - In Vitro Diagnostics UKAt ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global expertise.
As the world’s largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.
As a UK home-based In Vitro Diagnostics CRA at ICON, you will contribute to our clinical trial operations function, working in an enthusiastic, dynamic team.
This is a unique opportunity to move from a lab-based setting into a CRA role, embedded into a blue chip clinical diagnostics project, you will join your
colleagues in leading the design, planning, co-ordinating and conducting of all activities involved in initiating, monitoring and completing clinical research studies for in vitro diagnostics.
What You Will Do:
Your role will involve delivering clinical trial monitoring work to a high standard, working closely with your team and stakeholders.
Key responsibilities include:
- ensuring studies are conducted according to study protocols, operating procedures, and good clinical practice.
- validating product performance claims
- supplying data for critical Regulatory submissions
- defining the functional and clinical utility of investigation products
- supplying data for critical Regulatory submissions
- understanding and implementing federal regulations, helping to roll out SOPs in order to ensure that studies are adhering to FDA regulations, GCP, IVD directives and client policy.
Your Profile:
You will bring relevant In Vitro Diagnostics experience, ideally from a laboratory background, along with the following qualifications and skills.
Required qualifications and experience:
- University degree in medicine, science, or equivalent
- Practical knowledge of in vitro diagnostics and clinical trial processes
- Excellent written and verbal communication in English
- Good social skills enabling you to deal with queries in a timely manner
- Willingness to travel as required from your UK base (occasionally internationally)
Employment with ICON is contingent upon having the legal right to work in the country where the role is based.
Rewards & Benefits
ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.
Benefits may include:
- Competitive base salary and performance related incentives
- Health and wellbeing programmes including medical, dental, and vision coverage where applicable
- Retirement and pension plans
- Life assurance and disability coverage
- Employee assistance programmes and wellbeing resources
- Learning and development opportunities through structured training and career pathways
Benefits may vary depending on role and location.
Visit our careers site to read more about the benefits ICON offers.
Inclusion and Accessibility
ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.
If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.
Are you a current ICON Employee? Please click here to apply
Originally posted on Himalayas