In-House Clinical Research Associate I, Serbia, Poland, Spain

🔥 1 minute ago

🌐 Serbia, Spain, +1 more countries – Remote

🇷🇸 Serbia – Remote 🇪🇸 Spain – Remote 🇵🇱 Poland – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧪 Clinical Research

🚫👨‍🎓 No degree required

👻 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 start-up activities, including feasibility questionnaire coordination, confidentiality agreement collection, and essential document management • Review, track, and prepare site-related records for the Trial Master File (TMF) • Support Investigator Site File maintenance, TMF reconciliation, and quality control activities with field CRAs • Conduct remote monitoring activities and support pre-study, initiation, interim, and closeout visits under CRA or study leadership guidance • Build relationships with investigative sites through regular communication and ongoing study support • Review electronic data capture (EDC) systems and assist with query resolution and timely, accurate study data entry • Generate reports, maintain study trackers, and provide operational updates to Clinical Trial Managers and project teams • Support site staff management, including training documentation, regulatory document collection, system access requests, and delegation tracking • Assist with patient prescreening, screening, recruitment activities, and subject eligibility review tracking

🎯 Requirements

• Bachelor's degree in a medical, biological, physical, health, pharmacy, or related scientific discipline preferred • Combination of relevant education, training, and clinical research experience accepted • Clinical research experience as a Study Coordinator, Clinical Trial Assistant, or in another relevant clinical research role • Basic understanding of clinical research principles, processes, and Good Clinical Practice (GCP) requirements • Knowledge of FDA and/or EU regulations, ICH Guidelines, local regulatory requirements, and clinical research standard operating procedures • Familiarity with electronic clinical systems such as EDC, eCRF, and IVRS platforms • Strong organisational, planning, time management, and interpersonal communication skills • Proficiency in Microsoft Office applications • Fluent in English and a native local language • Fluency in at least one of French, German, Italian, or Spanish required

🏖️ Benefits

• Collaborative and inclusive environment • Growth and learning opportunities • Opportunity to contribute to meaningful clinical research improving patient care