In-House CRA II

🕒 Julho 4

🇲🇽 México – Remoto

⏰ Tempo Integral

🟢 Júnior

🟡 Pleno

🗣️🇺🇸🇬🇧 Inglês obrigatório

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Logo of Precision For Medicine

Precision For Medicine

1001 - 5000 funcionários

🏥 Saúde

💼 Consultoria

📦 Logística

💰 $75.000.000 Private Equity Round em 2015-12

Healthcare • Consulting • Logistics

A Precision For Medicine é uma organização líder especializada em apoiar o desenvolvimento e a comercialização de terapias inovadoras, particularmente em oncologia, doenças raras e condições autoimunes. Com uma gama abrangente de serviços, incluindo gestão de ensaios clínicos, serviços de laboratório e coleta de biospecimens, eles integram capacidades avançadas de biomarcadores e soluções de manufatura para simplificar os complexos processos de desenvolvimento clínico. Sua missão é acelerar a pesquisa e trazer soluções médicas que mudem a vida dos pacientes, superando as ineficiências tradicionais geralmente encontradas no cenário de desenvolvimento farmacêutico.

Descrição

• Provide overall support to study sites and clinical project teams engaged in clinical research studies • Adhere to applicable protocols, standard operating procedures (SOPs) and all applicable guidelines and regulatory requirements • Assist with the investigator recruitment activities utilizing phone scripts, questionnaires, study site materials and other tools • May assist in identifying study sites by performing site feasibility and recruitment tasks • Schedules internal and external meetings as required • Prepares Investigator Site Files including distribution to study sites • Performs ongoing essential document collection and review • Organizing and maintaining site level data in the trial master file (TMF) • Perform set ups and maintain site-related data in applicable clinical systems • Acts as site contact/liaison for study and site management issues • Ensures timely and complete data entry by site in EDC • Sends email blasts/newsletters and updates to study site personnel • Assists in providing logistics support in samples management and tracking • Supports investigators in fulfilling obligations regarding local submissions • Assists in data review inclusive of site level data review • Assist with study tracking via the CTMS • Documents site and Sponsor contact and study interactions in a timely manner • Assist in remote review of the electronic Investigator Site File • Assists with Investigational Product accountability • Consults with project team members regarding study site issues • Provides quality review of the amended site level informed consent template • Follows up with sites for trial invoices

🎯 Requisitos

• Bachelor's degree / international equivalent or equivalent combination of education and experience ideally in a business, scientific or healthcare discipline • Minimum of 2 years of relevant experience • High in proficiency in the Microsoft Office package of programs (Outlook, Word, Excel, and PowerPoint) • Customer service demeanor; demonstrate flexibility and teamwork • Ability to focus on detail for extended periods of time, high attention to accuracy • Fluency in English communication, verbally and in writing • Working knowledge of the drug development process • Ability to travel as needed

🏖️ Benefícios

• (No benefits listed)

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