自由职业者站点激活专员(研究启动/监管提交)
Freelance Site Activation Specialist (Study Start-Up / Regulatory Submissions)
职位名称:自由职业站点激活专家(研究启动/监管提交)
工作地点:英国剑桥郡剑桥
工作地点类型:远程
合同类型:全职
职位级别:
地点:英国(居家办公)
合同类型:自由职业
全职等效:1.0
开始时间:立即
持续时间:大约3-6个月
职位简介
我们正在寻找一位位于英国的有经验的自由职业站点激活专家,以支持临床试验启动和站点激活工作。
该职位的主要职责将包括英国监管文件的收集和准备、站点文件审查、知情同意书(ICF)的调整以及监管提交支持。成功候选人将与研究站点和内部研究团队密切合作,确保提交包完整、合规,并按照项目时间表交付。
主要职责
- 收集、审查并准备英国临床试验提交所需的站点和监管文件
- 根据研究要求和当地法规,支持监管包的准备和提交
- 执行并协调知情同意书(ICF)的调整及相关文件更新
- 审查关键站点文件以支持监管绿色通行证准备
- 直接与研究站点联系,获取、跟踪并解决未完成的文件
- 确保提交包的完整性、准确性和质量
- 维护研究追踪系统、时间线和提交记录
- 支持站点激活工作并监控项目里程碑的进展
- 与站点激活经理、监管事务、项目管理及其他跨职能团队紧密合作
- 确保符合ICH-GCP、当地英国法规和研究特定要求
任职要求
- 位于英国
- 至少2-3年站点激活、研究启动、监管事务或临床研究相关工作经验
- 在站点文件收集、审查和提交准备方面有丰富经验
- 有支持英国临床试验监管提交的经验
- 有进行ICF调整的经验
- 对站点激活和研究启动流程有扎实的理解
- 注重细节,能够管理多项优先事项和时间表
- 生命科学或相关领域的学士学位
- 英语沟通流利
查看英文原文
Job Title: Freelance Site Activation Specialist (Study Start-Up / Regulatory Submissions)
Job Location: Cambridge, Cambridgeshire, United Kingdom
Job Location Type: Remote
Job Contract Type: Full-time
Job Seniority Level:
Location: United Kingdom (Home-Based)
Contract Type: Freelance
FTE: 1.0
Start: Immediate
Duration: Approximately 3–6 months
About the Role
We are seeking an experienced Freelance Site Activation Specialist based in the United Kingdom to support clinical trial start-up and site activation activities.
The primary focus of this role will be UK submission document collection and preparation, site document review, Informed Consent Form (ICF) adaptations, and regulatory submission support. The successful candidate will work closely with investigative sites and internal study teams to ensure submission packages are complete, compliant, and delivered according to project timelines.
Key Responsibilities
- Collect, review, and prepare site and regulatory documentation required for UK clinical trial submissions
- Support the preparation and submission of regulatory packages in accordance with study requirements and local regulations
- Perform and coordinate Informed Consent Form (ICF) adaptations and associated document updates
- Review essential site documentation to support Regulatory Green Light readiness
- Liaise directly with investigative sites to obtain, track, and resolve outstanding documentation
- Ensure the completeness, accuracy, and quality of submission packages
- Maintain study tracking systems, timelines, and submission records
- Support site activation activities and monitor progress against project milestones
- Collaborate closely with Site Activation Managers, Regulatory Affairs, Project Management, and other cross-functional teams
- Ensure compliance with ICH-GCP, local UK regulations, and study-specific requirements
Requirements
- Based in the United Kingdom
- Minimum 2–3 years of experience in Site Activation, Study Start-Up, Regulatory Affairs, or Clinical Research
- Strong experience with site document collection, review, and submission preparation
- Experience supporting clinical trial regulatory submissions in the UK
- Experience performing ICF adaptations
- Solid understanding of site activation and study start-up processes
- Strong attention to detail and ability to manage multiple priorities and timelines
- Bachelor's degree in Life Sciences or a related field
- Fluent English communication skills, both written and verbal
If this role sounds of interest, please apply today!
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
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Originally posted on Himalayas