Senior Clinical Research Associate – Sponsor: Roche

• Monitor investigator sites using a risk-based monitoring approach
• Apply root cause analysis, critical thinking, and problem-solving to identify site process failures and corrective/preventive actions
• Ensure data accuracy through source document review, source data verification, and CRF review during on-site and remote monitoring
• Assess investigational product through physical inventory and records review
• Document observations in reports and letters according to timelines and business writing standards
• Escalate deficiencies and issues to clinical management and follow them through resolution
• Maintain contact with investigative sites between monitoring visits to confirm protocol compliance, issue resolution, and timely data recording
• Participate in investigator payment processes and collaborate on findings resolution
• Participate in investigator meetings and identify potential qualified investigators with the client
• Initiate clinical trial sites according to procedures and ensure protocol, regulatory, and ICH-GCP compliance
• Perform trial closeout and retrieve trial materials
• Ensure essential documents are complete and maintained according to ICH-GCP and applicable regulations
• Conduct on-site file reviews according to project specifications
• Provide trial status tracking and progress updates to the Clinical Team Manager
• Update study systems, including Clinical Trial Management Systems, according to study conventions

• University degree in a science-related field
• At least 5 years of independent monitoring experience in clinical development phases I–III
• Understanding of ICH-GCP and KGCP requirements
• Fluency in English
• Proven clinical monitoring skills
• Understanding of medical/therapeutic area knowledge and medical terminology
• Working knowledge of ICH GCPs, applicable regulations, and procedural documents
• Critical thinking, root cause analysis, and problem-solving skills
• Ability to manage Risk-Based Monitoring concepts and processes
• Good oral and written communication skills
• Customer focus, listening skills, attention to detail, and ability to identify underlying issues
• Organizational and time management skills
• Effective interpersonal skills
• Flexibility and adaptability
• Ability to work independently and in a team
• Solid Microsoft Office knowledge and ability to learn appropriate software

• Sign-on bonus
• Fully remote work arrangement
• Standard Monday–Friday work schedule