Clinical Research Associate I

• 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 data review, source data verification, and case report form review during on-site and remote monitoring
• Assess investigational products through physical inventory and records review
• Document observations in reports and letters using approved 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
• Conduct monitoring tasks according to the approved monitoring plan
• Participate in the investigator payment process and investigator meetings
• Identify potential investigators and initiate clinical trial sites according to procedures, protocol, regulatory, and ICH-GCP obligations
• 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
• Provide trial status tracking and progress updates
• Maintain complete and accurate study systems, including Clinical Trial Management Systems
• Facilitate communication among investigative sites, the client company, and internal project teams
• Respond to company, client, and regulatory requirements, audits, and inspections
• Complete expense reports and timesheets
• Assist with project publications/tools and contribute ideas and process-improvement initiatives

• Bachelor's degree in a life sciences related field, or Registered Nursing certification, or equivalent formal academic/vocational qualification
• Minimal clinical monitoring experience comparable to 2 years
• Clinical environment experience in clinical trials, medical terminology, medical research, clinical research, health care, or a health sciences field with formal training in medical terminology
• Ability to perform root cause analysis, critical thinking, and problem-solving
• Knowledge of ICH-GCP, applicable regulations, and clinical trial procedures
• Ability to travel generally 60–80%, with a travel requirement higher than 75%
• Ability to perform frequent drives to site locations and extended overnight stays
• Ability to work in office, laboratory, clinical, and/or home office environments
• Ability to comply with sponsor/client/site requirements, including possible disclosure of vaccination status or other personal information
• Ability to use required personal protective equipment when exposed to biological fluids or infectious organisms

• Fully remote work mode
• Standard Monday–Friday work schedule