In-House Clinical Research Associate I/II – Spanish, English, Portuguese

🔥 0 minutes ago

🌐 Argentina, Brazil – Remote

🇦🇷 Argentina – Remote 🇧🇷 Brazil – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧪 Clinical Research

👻 Ghost score 10%

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Worldwide Clinical Trials

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Worldwide Clinical Trials is a global contract research organization (CRO) that provides comprehensive clinical trial services. They specialize in supporting studies across diverse therapeutic areas such as oncology, cardiology, and rare diseases. With over 30 years of experience, Worldwide Clinical Trials emphasizes personalized support and customized solutions throughout the entire lifecycle of drug development. Their services include clinical monitoring, data management, patient recruitment, and regulatory consulting, ensuring precision and tailored attention for each clinical trial.

📋 Description

• Support site management activities throughout the study lifecycle, including feasibility, study initiation, interim and remote monitoring, and close-out activities • Maintain regular communication with assigned sites and partner with Clinical Trial Managers and field CRAs • Review site documentation for quality and completeness • Support Trial Master File (TMF) filing and reconciliation and help maintain Investigator Site Files (ISFs) • Review electronic data capture (EDC) records and assist sites with resolving data management and vendor queries • Prepare CRAs for site visits by tracking and communicating action items, protocol deviations, outstanding queries, study supplies, training, and other open activities • Coordinate study materials, support site staff changes and system access, and help keep training, qualifications, delegation, and regulatory documentation current • Support site prescreening, screening, recruitment, and Subject Eligibility Review tracking • Maintain study trackers, retrieve information from study-specific portals and systems, and provide timely updates to Clinical Trial Managers and project teams • Serve as a key operational contact for clinical research activities when appropriate

🎯 Requirements

• Four-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy, or another related science is preferred • Alternatively, a two-year college curriculum or equivalent education/training plus at least one year of relevant clinical research experience may be considered • Alternatively, other relevant education/training plus at least two years of clinical research experience may be considered • Basic understanding of clinical research principles and processes • Knowledge of applicable FDA and/or EU regulations, ICH Guidelines, local regulatory requirements, and standard operating procedures • Strong written and verbal communication skills • Planning, organization, and time-management skills • Basic knowledge of Microsoft Office • Familiarity with IVRS and electronic CRF systems • Proficiency in spoken and written English, Spanish, and Portuguese • Fluency in the local languages of the countries under your responsibility

🏖️ Benefits

• Collaborative and inclusive work environment • Growth and learning opportunities • Opportunity to contribute to meaningful clinical research improving patients' lives • Remote work arrangement