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

• 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

• 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

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