CRA II

• 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 sponsor/monitoring-environment procedures
• Ensure trials follow approved protocols, ICH-GCP guidelines, applicable regulations and SOPs
• Maintain audit readiness and collaborative relationships with investigational sites
• 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 CRF review
• Assess investigational product inventory and records
• Document observations in reports and letters and escalate deficiencies through resolution
• Maintain contact with sites between monitoring visits to verify protocol compliance, issue resolution and timely data recording
• Participate in investigator payments, meetings and site identification
• Initiate clinical trial sites and perform trial closeout and retrieval of materials
• Ensure essential documents are complete and conduct on-site file reviews
• Provide trial status and progress reports to the Clinical Team Manager
• Update study systems such as the Clinical Trial Management System
• Facilitate communication among 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, tools and process-improvement initiatives

• Bachelor's degree in a life sciences related field, or Registered Nursing certification, or equivalent relevant formal academic/vocational qualification
• At least 1 year of experience as a clinical research monitor, or completion of the PPD Drug Development Fellowship
• Valid driver's license where applicable
• Proven clinical monitoring skills
• Understanding of medical/therapeutic area knowledge and medical terminology
• Working knowledge of ICH GCPs, applicable regulations and procedural documents
• Risk-Based Monitoring concepts and processes
• Root cause analysis and problem-solving skills
• Good oral and written communication skills, including communication with medical personnel
• Good organizational and time management skills
• Effective interpersonal skills and attention to detail
• Ability to remain flexible and adaptable
• Ability to work independently or in a team
• Solid knowledge of Microsoft Office and ability to learn appropriate software
• Good English language and grammar skills
• Good presentation skills
• Willingness and ability to travel frequently, generally 60–80%, including possible extended overnight stays
• Ability to work in office, laboratory, clinical and/or home office environments
• Ability to use required personal protective equipment

• Fully remote work mode
• Standard Monday-Friday work schedule
• Frequent travel expenses may be covered (not explicitly stated)
• Personal protective equipment such as protective eyewear, garments and gloves