Clinical Research Associate II – FSP

• Perform and coordinate clinical monitoring and site management activities
• Conduct remote and on-site investigator site visits to assess protocol and regulatory compliance
• Monitor investigator sites using a risk-based monitoring approach
• Apply root cause analysis, critical thinking and problem-solving to identify process failures and corrective/preventive actions
• Ensure data accuracy through source document review, source data verification and case report form review
• Assess investigational product inventory and records
• Document observations in reports and letters
• Escalate deficiencies and follow issues through resolution
• Maintain contact with investigative sites between monitoring visits
• Conduct monitoring tasks according to approved monitoring plans
• Participate in investigator payments and investigator meetings
• Identify potential investigators and initiate clinical trial sites
• Perform trial closeout and retrieve trial materials
• Ensure essential documents comply with ICH-GCP and applicable regulations
• Conduct on-site file reviews
• Provide trial status and progress reports to the Clinical Team Manager
• Update clinical study systems, including Clinical Trial Management Systems
• 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 and tools
• Contribute to project initiatives and process improvement

• Bachelor's degree in a life sciences-related field, or Registered Nursing certification, or equivalent relevant formal academic/vocational qualification
• Valid driver's license where applicable
• Previous experience comparable to 1 year as a clinical research monitor, or completion of PPD Drug Development Fellowship
• Combination of appropriate education, training and/or directly related experience may be considered equivalent
• 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
• Ability to communicate effectively with medical personnel
• Customer focus, listening skills and attention to detail
• Organizational and time management skills
• Effective interpersonal skills
• Flexibility and adaptability
• Ability to work independently or in a team

• Comprehensive health and wellbeing benefits
• Wellness programs
• Employee Assistance Program providing confidential support for personal and work-related issues
• Flexible work arrangements
• Generous leave policies
• Option to purchase additional leave
• Paid birthday leave
• Company-paid parental leave
• Paid volunteer time
• Online courses via Thermo Fisher Scientific University Plus and LinkedIn Learning
• Workshops and mentorship programs
• Learning and skill development opportunities