Clinical Research Associate II – FSP Business Unit

• Perform and coordinate clinical monitoring and site management activities
• Conduct remote or on-site visits to assess protocol and regulatory compliance
• Manage required documentation and sponsor or monitoring-environment procedures
• Ensure trials follow approved protocols, ICH-GCP guidelines, applicable regulations and SOPs
• 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 through physical inventory and records review
• Document observations in reports and letters and escalate deficiencies to clinical management
• Maintain contact with investigative sites between monitoring visits and follow issues through resolution
• Participate in investigator payment processes and investigator meetings
• Identify potential investigators and initiate clinical trial sites
• Perform trial close-out and retrieve trial materials
• Ensure essential documents are complete and conduct on-site file reviews
• Provide trial status tracking and progress updates to the Clinical Team Manager
• Update study systems such as the Clinical Trial Management System
• Facilitate communication between investigative sites, the client company and the PPD project team
• Respond to company, client and regulatory requirements, audits and inspections
• Complete administrative tasks including expense reports and timesheets
• Assist with project publications/tools and contribute to process-improvement initiatives

• Bachelor's degree in a life sciences related field, or Registered Nursing certification or equivalent and relevant formal academic/vocational qualification
• Previous experience comparable to 1 year as a clinical research monitor, or completion of 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
• Critical thinking, root cause analysis and problem-solving skills
• Ability to manage Risk Based Monitoring concepts and processes
• Good oral and written communication skills
• Customer focus, listening skills and attention to detail
• Organizational and time management skills
• Effective interpersonal skills
• Flexibility and adaptability
• Ability to work independently or as part of a team
• Microsoft Office proficiency and ability to learn appropriate software
• Good English language and grammar skills
• Good presentation skills
• Ability to travel frequently, generally 60–80%, including possible extended overnight stays
• Ability to work in environments with potential exposure to biological fluids and infectious organisms
• Ability to use required personal protective equipment, including protective eyewear, garments and gloves

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