Senior Clinical Research Associate – FSP, with Sign-on Bonus

• 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 compliance and issue resolution
• Participate in investigator payment processes and findings resolution
• Participate in investigator meetings and identify potential investigators with the client
• Initiate clinical trial sites in accordance with procedures, protocol, regulatory and ICH-GCP obligations
• Perform trial close-out 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 according to agreed study conventions

• University degree in a science related field
• At least 3 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
• Good organizational and time management skills
• Effective interpersonal skills
• Attention to detail
• 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
• On-site and remote monitoring activities
• Full-time work schedule, Monday–Friday