Principal Clinical Research Associate – FSP

• 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 SDR, SDV 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 adherence, issue resolution and timely data recording
• Participate in investigator payment processes and resolve findings with project team members
• Participate in investigator meetings and identify potential investigators with the client
• Initiate clinical trial sites in compliance with protocol, regulatory requirements and ICH GCP obligations
• Perform trial closeout and retrieval of trial materials
• Ensure essential documents are complete and conduct on-site file reviews
• Provide trial status tracking and progress updates to the Clinical Team Manager
• Update study systems, including the Clinical Trial Management System, according to study conventions

• University degree in a science related field
• At least 7 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
• Ability to maintain 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 and attention to detail
• Good organizational and time management skills
• Effective interpersonal skills
• Flexibility and adaptability
• Ability to work in a team or independently
• Solid knowledge of Microsoft Office and ability to learn appropriate software

• Sign-on bonus