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 timely 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 according to procedures, protocol, regulatory, and ICH GCP requirements
• 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
• Track trial status and provide progress updates
• Maintain complete and accurate study systems, including the Clinical Trial Management System
• Facilitate communication among 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/tools and contribute ideas for process improvement

• 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
• Experience in a clinical environment involving clinical trials, medical terminology, medical research, clinical research, health care, or a health sciences field with formal training in medical terminology
• Ability to comply with sponsor/client/site requirements, including potential disclosure of vaccination status or other personal information
• Ability to use personal protective equipment, including protective eyewear, garments, and gloves
• Ability to travel frequently, generally 60–80% or more for some individuals
• Ability to make frequent drives to site locations and potentially stay overnight for extended periods

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