Site Management Associate I

🕒 Setembro 18

🇦🇷 Argentina – Remoto

⏰ Tempo Integral

🟢 Júnior

🟡 Pleno

🗣️🇺🇸🇬🇧 Inglês obrigatório

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Logo of PSI CRO AG

PSI CRO AG

1001 - 5000 funcionários

Fundada em 1996

🏥 Saúde

💼 Consultoria

📦 Logística

Healthcare • Consulting • Logistics

PSI CRO AG é uma organização global de pesquisa por contrato (CRO) especializada na condução de ensaios clínicos. A empresa foca na entrega de ensaios clínicos pivotais de Fase 2 e Fase 3 em diversas áreas terapêuticas, incluindo Doenças Inflamatórias Intestinais, Oncologia, Hematologia, Doenças Infecciosas, Esclerose Múltipla e Doenças Raras. A PSI utiliza uma plataforma tecnológica proprietária para planejamento de ensaios clínicos e controle financeiro, garantindo que os estudos sejam conduzidos no prazo e dentro do orçamento. A empresa é reconhecida por sua expertise, qualidade, compatibilidade e confiabilidade, tendo sido premiada no CRO Leadership Awards por vários anos consecutivos.

Descrição

• Serve as the main point of contact between site personnel and CRA involved in the project, helping with query resolution and EDC completion • Serve as the primary sites’ contact point for vendors, study supplies, and access management • Ensure completion of pre-study testing of local site facilities, including scans, MRI/CT qualification questionnaires, and test ECGs • Assist Monitors with prompt completion of subject event and site event information in CTMS • Track resolution status of site issues and action items in CTMS • Manage ordering, receipt, inventory storage, distribution, return/recall, and reconciliation of clinical supplies • Ensure regulatory and ethics committee submissions and notifications, staying current with local regulations and dispositions • Coordinate preparation for and follow-up on site, TMF, and systems audits and inspections • Manage the TMF at site and country level and regularly file documents • Prepare, distribute, and update Investigator Site Files (ISF) and ISF checklists • Arrange and track initial and ongoing project training for site teams in vendor-related systems • Review document management and translation status of the study • Ensure proper safety information flow with investigative sites

🎯 Requisitos

• Only CVs in English will be accepted • College/University Degree in Life Sciences • Administrative work experience, preferably in an international settings • Prior experience working as CTA for CROs • Prior experience working in Clinical Research • Local regulations knowledge • Full working proficiency in English • Proficiency in MS Office applications • Ability to plan and work in a dynamic team environment • Communication and collaboration skills

🏖️ Benefícios

• Employees can work remotely • Advance your career in clinical research, coordinating a variety of tasks and learning new things while growing with the company

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