高级CRA 1 - 现场管理
Sr. CRA 1 - Site Management
职位名称：高级临床研究助理 1 - 站点管理
工作地点：伦敦，大伦敦，英国
工作地点类型：远程办公
工作合同类型：全职
职位级别：
加入我们，共同推动医疗健康进步
IQVIA UK 的站点管理团队正在扩大，我们正在招聘两名高级临床研究助理。加入我们，打造有意义的职业生涯，产生实际影响，并继续你的职业发展。
职位概述
执行监查和站点管理工作，确保站点按照研究方案、适用法规和指南以及申办方要求进行研究并报告研究数据。
主要职责
• 根据合同工作范围和良好临床实践，执行站点监查访问（选择、启动、监查和结清访问）。
• 与站点合作，根据项目需求调整、推动并跟踪受试者招募计划，以提高可预测性。
• 向指定站点提供方案及相关研究培训，并建立与站点的定期沟通渠道，以管理持续的项目期望和问题。
• 评估与方案正确实施和适用法规遵循相关的站点实践质量和完整性。适时升级质量问题。
• 通过跟踪监管提交和批准、招募和入组、病例报告表（CRF）完成和提交，以及数据查询生成和解决来管理指定研究的进展。可能支持启动阶段。
• 确保站点文件的复印件/原件（如需要）可用于归档到试验主文件（TMF），并验证研究者站点文件（ISF）是否符合 GCP 和当地监管要求。
• 创建并维护有关站点管理、监查访问发现和行动计划的适当文档，通过提交定期访问报告、生成跟进信函和其他所需的研究文档。
• 与研究团队成员协作并联络，以提供项目执行支持。
• 如适用，可能负责根据每个站点的情况支持制定项目受试者招募计划。
• 如适用，可能负责根据已签署的临床试验协议进行站点财务管理，并根据当地要求获取发票。
任职资格
• 科学学科或医疗保健领域的学士学位优先。需
• 至少 2 年
查看英文原文
Job Title: Sr. CRA 1 - Site Management
Job Location: Manchester, Greater Manchester, United Kingdom
Job Location Type: Remote
Job Contract Type: Full-time
Job Seniority Level:
Join Us on Our Mission to Drive Healthcare Forward
IQVIA UK’s Site Management team is growing, and we’re hiring two Senior CRAs. Join us to build a meaningful career, drive real impact, and continue your professional growth.
Job Overview
Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.
Essential Functions
• Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and Good Clinical Practice.
• Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.
• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
• Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.
• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
• Collaborate and liaise with study team members for project execution support as appropriate.
• If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.
• If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.
Qualifications
• Bachelor's Degree Degree in scientific discipline or health care preferred. Req
• Requires at least 2 years of on-site monitoring experience. Req
• Good knowledge of, and skill in applying, applicable clinical research regulatory requirements.
• i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Good therapeutic and protocol knowledge as provided in company training.
• Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).
• Written and verbal communication skills including good command of English language.
• Organizational and problem-solving skills.
• Effective time and financial management skills.
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
- Please note - this role is not eligible for UK visa sponsorship*
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