Clinical Trial Coordinator Intern

Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description

Join Us as a Clinical Trial Coordinator Intern – Make an Impact at the Forefront of Innovation
We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.

As part of our global team, you’ll have the opportunity to provide administrative and technical support to the Project Team. As a Clinical Trial Coordinator, you'll support audit readiness by ensuring files are reviewed according to the schedule detailed in the organization's SOP and department guidance documents. You will provide administrative support for site activation activities and aid in the development of the critical path for site activation within assigned projects to support rapid site activations. Representing CRG personnel, you may utilize local language, organization systems, external site lists, and sponsor directives to develop and review site lists that are suitable for strategic needs of feasibility activities and to provide local input into the site tiering process. You may act as a buddy during the onboarding phase and provide training to new staff as needed. Additionally, you will support departmental and cross-functional initiatives for process improvements and enhancements.

What You’ll Do:
• Coordinates, oversees and completes functions on assigned trials activities detailed on the task matrix.
• Performs department, Internal, Country and Investigator file reviews as assigned and documents findings in appropriate system.
• Ensures allocated tasks are performed on time, within budget and to a high quality standard. Proactively communicates any risks to project leads and line manager as appropriate.
• Supports the maintenance of study specific documentation and global support with specific systems, tools and trackers including but not limited to: study team lists, tracking of project specific training requirements, system access management for organization/vendor/clients, and tracking of project level activity plans in appropriate system. Ensures (e)TMF is up to date by following file review schedules and documents findings in appropriate system.
• Provides system support (i.e. CTMS, Activate, & eTMF).
• Supports RBM activities.
• Performs administrative tasks on assigned trials including but not limited to: timely processing of documents sent to Client (e)TMF as assigned, performing (e)TMF reviews, performing mass mailings and communications as needed, providing documents and reports to internal team members.
• Supports scheduling and organization of client and/or internal meetings with completion of related meeting minutes.
• Reviews and tracks local regulatory documents.
• Transmits documents to client and centralized IRB/IEC.
• Analyzes and reconciles study metrics and findings reports. Assists with clarification and resolution of findings related to site documentation.
• Maintains vendor trackers.
• Assists with coordination, compilation and distribution of Investigator Site File (ISF) and Pharmacy binder materials and non-clinical study supplies to sites.
• Assists with study-specific translation materials and translation QC upon request.
• May attend Kick off meeting and take notes when required.

Education and Experience Requirements:
• High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification.
• Bachelor's degree preferably in Life Sciences (Pharmacy, Medicine, Biology, etc.)
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 1 year).
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities:
• Ability to work in a team or independently as required
• Strong organizational skills and attention to detail, with proven ability to handle multiple tasks

工作安排
标准工作制（周一至周五）

工作环境
办公室环境

工作描述

加入我们，担任临床试验协调员实习生 - 在创新前沿发挥影响力

在过去5年中，我们成功支持了前50家制药公司和750多家生物技术公司，横跨100多个国家的2700多项临床试验。

作为我们全球团队的一员，您将为项目团队提供行政和技术支持。作为临床试验协调员，您将通过确保根据组织的SOP和部门指导文件中详细的时间表审查文件来支持审计准备。您将为研究中心启动活动提供行政支持，并协助制定指定项目中的研究中心启动关键路径，以支持快速启动。作为CRG人员的代表，您可能会利用当地语言、组织系统、外部研究中心列表和申办方指导方针，制定和审查适合可行性活动战略需求的研究中心列表，并为研究中心分级过程提供本地输入。您可能在入职阶段担任伙伴角色，并根据需要为新员工提供培训。此外，您还将支持部门和跨职能的流程改进和增强倡议。

您将负责：
• 协调、监督并完成任务矩阵上详细指定的试验活动功能。
• 执行指定的部门、内部、国家和研究者文件审查，并在适当系统中记录发现。
• 确保分配的任务按时、在预算内并以高质量标准完成。根据需要主动向项目负责人和直线经理传达任何风险。
• 支持维护研究特定文档和通过特定系统、工具和跟踪器提供的全球支持，包括但不限于：研究团队列表、跟踪项目特定培训要求、组织/供应商/客户的系统访问管理，以及在适当系统中跟踪项目级活动计划。通过遵循文件审查时间表并在适当系统中记录发现，确保(e)TMF是最新的。
• 提供系统支持（即CTMS、Activate和eTMF）。
• 支持RBM活动。
• 执行指定试验的行政任务，包括但不限于：及时处理分配给客户(e)TMF的文件，执行(e)TMF审查，根据需要进行群发邮件和通讯，向内部团队成员提供文件和报告。
• 支持安排和组织客户和/或内部会议，并完成相关会议纪要。
• 审查和跟踪当地监管文件。
• 向客户和集中IRB/IEC传输文件。
• 分析和协调研究指标和发现报告。协助澄清和解决与研究中心文档相关的发现。
• 维护供应商跟踪器。
• 协助协调、汇编和分发研究者文件(ISF)和药房装订材料以及非临床研究用品到各研究中心。
• 根据要求协助研究特定的翻译材料和翻译质量控制。
• 必要时可参加启动会议并做记录。

教育及经验要求：
• 高中/中学文凭或同等学历以及相关正规学术/职业资格。
• 学士学位， preferably in Life Sciences (Pharmacy, Medicine, Biology, etc.)
• 提供履行工作所需的知识、技能和能力的相关经验（相当于0至1年）。
在某些情况下，适当的教育、培训和/或直接相关经验的组合将被视为足以满足职位要求。

知识、技能和能力：
• 能够在团队中独立工作或根据需要独立工作
• 强大的组织能力和注重细节，具有处理多项任务的证明能力

⚑ 岗位信息收录自公开招聘页（ATS 官方），以雇主官网为准