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 document review, source data verification and case report form review
• Assess investigational product 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 investigator payment processes and investigator meetings
• Help identify potential investigators and initiate clinical trial sites in compliance with protocols, regulations 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 according to project specifications
• Provide trial status tracking and progress updates
• Keep study systems complete, accurate and updated, including Clinical Trial Management Systems
• Facilitate communication between investigative sites, the client company and internal project teams
• Respond to company, client and regulatory requirements, audits and inspections
• Complete administrative tasks such as expense reports and timesheets
• Assist with project publications and tools, share suggestions, and contribute to 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 in a 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 conduct risk-based monitoring and apply root cause analysis, critical thinking and problem-solving skills
• Knowledge of ICH-GCP, applicable regulations, clinical trial protocols and monitoring plans
• Ability to use clinical trial systems, including Clinical Trial Management Systems
• Ability to comply with sponsor, client and site requirements, including disclosure of vaccination status or other personal information when required
• Ability to travel frequently, generally 60–80%, with a stated travel requirement higher than 75%
• Ability to make frequent drives to site locations and undertake extended overnight stays
• Ability to work with potential exposure to biological fluids and infectious organisms
• Ability to work in fluctuating and/or extreme temperatures on rare occasions

• Fully remote work mode
• Standard Monday–Friday work schedule
• Work performed in office/laboratory/clinical and/or home office environments
• Personal protective equipment provided/required, including protective eyewear, garments and gloves