Senior Clinical Research Associate

• Monitor clinical trials and observational studies for protocol adherence
• Manage site activities and oversee data collection and integrity
• Ensure sites conduct studies and report data according to regulations, guidelines, and sponsor requirements
• Apply project-specific protocols
• Perform remote and on-site monitoring according to project timelines
• Schedule travel according to project and UBC travel policies
• Submit expense reports within UBC requirements
• Attend project, department, and one-to-one manager meetings
• Complete site monitoring reports and letters with minimal corrections
• Follow up on site issues and action items within required timelines
• Enter site visits, monitoring reports, follow-up letter dates, and site contacts into CTMS
• Monitor EDC data entry and assist with eCRF resolution
• Review Investigator Site Files and reconcile Investigational Product
• Maintain regular contact with assigned sites
• Complete SOP reviews, training assessments, and documentation
• Perform Site Management and Monitoring activities according to project plans and timelines
• Review and update Patient Information Sheets and Informed Consent documents according to local requirements
• Translate study communications between English and the local language as needed
• Prepare, submit, and track CTIS, Competent Authority, and Ethics Committee regulatory applications
• Conduct contract negotiations with sites, foundations, and local Research & Development departments
• Review and confirm site payment details
• Maintain eTMF and track essential documents
• Conduct study feasibility assessments with sites
• Perform other assigned duties that may align with other UBC departments

• Bachelor’s degree – Life Science preferred or equivalent years of industry and clinical research experience
• Minimum of 24 months’ clinical research experience, specifically in site management and remote monitoring
• Preferably at least 6 months’ on-site monitoring experience
• Knowledge of medical terminology and regulatory guidelines, including local legislation
• Strong attention to detail and excellent organizational skills
• Ability to communicate effectively
• Excellent critical thinking and resolution skills
• Ability to deliver accurate work and adhere to deadlines in a fast-paced environment
• Good written and verbal communication skills in English and local language, as applicable
• Experience and familiarity with CTMS, eTMF, EDC, and Microsoft Office applications
• Willingness and ability to travel up to 50% in the European region

• Equal opportunity employer
• Diverse, equitable and inclusive workplace culture
• Career growth and meaningful impact opportunities