Clinical Research Associate 2

• Perform site monitoring visits, including selection, initiation, monitoring, and close-out visits
• Drive and track subject recruitment plans with study sites
• Administer protocol and study training to assigned sites
• Establish regular communication with sites to manage project expectations and issues
• Evaluate site practices for protocol quality, integrity, and regulatory adherence
• Escalate quality issues as appropriate
• Track regulatory submissions, approvals, recruitment, enrollment, CRF completion, and data queries
• Support the study start-up phase when applicable
• Ensure site documents are available for Trial Master File filing
• Verify Investigator's Site File maintenance according to GCP and local requirements
• Maintain site management and monitoring documentation, visit reports, follow-up letters, and study documents
• Collaborate with study team members to support project execution
• Support development of site-level subject recruitment plans when applicable
• Support site financial management and invoice retrieval when applicable

• Bachelor's Degree in scientific discipline or health care preferred
• Requires at least 1.5 years of on-site monitoring experience
• Equivalent combination of education, training and experience may be accepted
• Organizational, time management and problem-solving skills
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients
• Flexibility to travel
• Driver’s license
• Knowledge of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
• Ability to perform site monitoring visits and manage clinical study documentation
• All application information and credentials must be truthful and complete

• Collaborative culture
• Home-based work in Spain
• Opportunity to work across multiple therapeutic areas
• Diversity, inclusion, and belonging culture