Clinical Research Associate

Hace 2 días

Madrid, España IQVIA Jornada completa
Experteer Overview In this field-based role, you monitor clinical sites to ensure study conduct and data reporting align with protocol, GCP/ICH, and sponsor requirements. You will work with sites to drive recruitment, train on protocols, and maintain quality and regulatory documents. You’ll track study progress, manage TMF/ISF filing, and collaborate with cross-functional teams to support study execution. This position offers exposure to regulatory compliance, data integrity, and site-level coordination in a global clinical research environment. Compensaciones / Beneficios
• Perform site monitoring visits (selection, initiation, ongoing, close-out) per scope and regulatory requirements (GCP/ICH)
• Drive and track subject recruitment plans to meet project needs
• Administer protocol-related training to sites and maintain regular communications
• Evaluate site practices for protocol conduct and regulatory adherence; escalate quality issues
• Track regulatory submissions, approvals, recruitment, CRF completion, data query generation and resolution; may support start-up
• Ensure site documents (TMF, ISF) are filed and compliant with GCP/ICH and local requirements
• Document site management activities with visit reports, follow-up letters, and related study documentation
• Collaborate with study team for project execution support
• May support site recruitment plan development per site; may handle site financial management per agreement Responsabilidades
• Bachelor's Degree in scientific discipline or health care (preferred)
• Equivalent combination of education, training and experience may be accepted
• CRA training or prior monitoring experience may be required by some organizations
• Knowledge of GCP and ICH guidelines
• Therapeutic and protocol knowledge as provided by training
• Computer

skills:
Word, Excel, PowerPoint; use of laptop and mobile devices as applicable
• Strong written and verbal English communication
• Organizational and problem-solving skills; effective time and financial management
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients Requisitos principales •