Senior Start Up Associate - Freelance in Greece
咨询人员希望成为我们临床运营团队的高级创业员 (SSU) ,拥有在希腊监管和创业经验0.5 FTE?高级创业者负责通过 CTIS 对第二部分，以及其他适用的国家监管要求管理 CTR 级别下的研究创业活动。并负责创业国家的及现场水平的研究创业成果。这是一个体验丰富的生物马帕斯临床运作团队中希腊的学习创业员工 (SUA). 你有能力和动机，以致力于在一个高度激励的专业的 CO 和 SSU 团队工作并获得更多经验？请将简历提交给英语。责任：· 在国家和地点层面开展并管理开始项目学习活动。·准备，提交和跟踪初步申请和修改，向合格当局和伦理委员会 (CA/CEC/LEC) /IRB 和其他机构进行处理。·与合格当局和道德委员会 (CA /CEC/ LEC) / IRB 和其他机构提供官方沟通，如果适用的话，编制响应提交包来解决权威问题。·从提交的角度，就进口/出口要求咨询研究团队；· 适应试验材料 （ICF,标签，患者文件等）来满足当地国家的需求。· 编译 IP 发布/必要文件包来确保网站及时激活。· 与站点/机构支持合同谈判 (CTA). ·管理转化请求和对提交所需的本地语言试验文档进行翻译审查。· 保持学习管理数据库更新并根据 SOP 和研究计划将试验信件存入 TMF 中。·与研究团队，站点和研究总部团队持续更新状态。· 生物科学，护理或相关领域的学士学位 · 英语流利 · 最近至少2~3年的实际经验在希腊开展创业活动中管理通过 CTIS 进行 CTR 提交 · 全球和国家级临床研究监管要求的强大知识。· 经验丰富的微软办公套件用户 · 注意细节和时间管理技能 · 在研究团队以及客户/供应商内部的工作和协作
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Freelance opportunity in Greece! Interested to join our Clinical Operations team as a Senior Start Up Associate (SSU) with regulatory and start up experience in Greece for 0.5 FTE?
Senior Start Up Associate is responsible for managing study start-up activities at country and sites’ levels under CTR via CTIS for Part 2 and as per other applicable country regulatory requirements and is accountable for the start-up country and site levels study start-up deliverables.
This is a position for the experienced Study Start-up Associate (SUA) in Greece within Biomapas Clinical Operations team.
You have energy and motivation to work in a highly motivated and dedicated CO and SSU teams and to gain more experience?
Submit your CV in the English language for consideration.
Responsibilities:
- Perform and manage start-up a activities for the assigned studies at country and site levels.
- Prepare, submit, and track initial applications and amendments to Competent Authorities and Ethics Committees (CA/CEC/LEC) / IRBs and other bodies if applicable.
- Manage official communication with Competent Authorities and Ethics Committees (CA/CEC/LEC) /IRBs and other bodies if applicable, prepare response submission packages to address authority queries.
- Advise study teams on local legislation from submission perspective, on import/export requirements;
- Adapt trial materials (ICFs, labels, patient documents etc.) to meet local country requirements.
- Compile IP release/Essential document packages to ensure timely sites activation.
- Support contract negotiations (CTAs) with sites/institutions.
- Manage translation request and translations review of required for submissions local-language trial documentation.
- Keep study management databases updated and file trial correspondence into the TMF as per SOPs and study plans.
- Maintain ongoing status updates with study teams, sites, study PM team.
Requirements
- Bachelor’s degree in Life Sciences, Nursing, or related field
- Fluent English language
- Minimum 2-3 years of recent actual experience with Start up activities in Greece managing submission under CTR via CTIS
- Strong knowledge in clinical research regulatory requirements at country and global levels as per GCP.
- Experienced user of Microsoft Office Suite
- Attention to detail and time-management skills
- Team work and collaboration within study teams as well as Clients/vendors as applicable
Originally posted on Himalayas