CRA / Sr. CRA

• Perform and coordinate clinical monitoring and site management activities
• Conduct remote and on-site visits to assess protocol and regulatory compliance
• Manage required clinical trial documentation and ensure audit readiness
• Ensure trials follow approved protocols, ICH-GCP guidelines, applicable regulations, and SOPs
• Monitor investigator sites using a risk-based monitoring approach
• Identify site process failures, perform root cause analysis, and implement corrective/preventive actions
• Ensure data accuracy through SDR, SDV, and CRF review
• Assess investigational product inventory and records
• Document observations and escalate deficiencies and issues through resolution
• Maintain regular contact with investigative sites between monitoring visits
• Participate in investigator payment processes and investigator meetings
• Identify potential investigators and initiate clinical trial sites
• Perform trial closeout and retrieve trial materials
• Ensure essential documents are complete and properly maintained
• Conduct on-site file reviews
• Track trial status and provide progress updates to the Clinical Team Manager
• Update study systems, including Clinical Trial Management Systems
• Facilitate communication between investigative sites, the client company, and the PPD project team
• Respond to company, client, and regulatory requirements, audits, and inspections
• Complete expense reports and timesheets
• Assist with project publications and tools
• Contribute to project initiatives and process improvement

• Bachelor's degree in a life sciences related field
• Previous experience providing the knowledge, skills, and abilities to perform the job, comparable to 1+ years as a clinical research monitor
• International monitoring experience
• Frequent travel, generally 60–80%, with possible extended overnight stays
• No restriction to travel internationally
• Lives within an international airport location
• Ability to conduct remote or on-site clinical monitoring visits
• Knowledge of ICH-GCP guidelines, applicable regulations, and SOPs
• Experience with risk-based monitoring, root cause analysis, critical thinking, and problem-solving
• Experience with source document review (SDR), source data verification (SDV), and CRF review
• Ability to assess investigational product inventory and records
• Clinical trial site management and essential document management experience
• Familiarity with clinical trial management systems
• Ability to respond to regulatory requirements, audits, and inspections

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