Senior CRA, Level II

• Perform and coordinate clinical monitoring and site management activities
• Conduct remote and on-site visits to assess protocol and regulatory compliance
• Manage clinical trial documentation, procedures and sponsor guidelines
• Ensure trials follow approved protocols, ICH-GCP guidelines, regulations and SOPs
• Maintain audit readiness and relationships with investigational sites
• Monitor investigator sites using risk-based monitoring, root cause analysis 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
• Escalate deficiencies and follow issues through resolution
• Maintain contact with investigative sites between monitoring visits
• Conduct monitoring tasks according to the monitoring plan
• Participate in investigator payments and meetings
• Identify and initiate qualified clinical trial sites
• Perform trial closeout and retrieve trial materials
• Ensure essential documents are complete and compliant
• 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 sites, the client company and the PPD project team
• Respond to company, client and regulatory audits and inspections
• Complete expense reports and timesheets
• Contribute to project publications, tools, process improvements and other initiatives

• Bachelor's degree in a life sciences related field or Registered Nursing certification or equivalent and relevant formal academic / vocational qualification
• Approximately 1 year of experience 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 and in a team
• Solid knowledge of Microsoft Office and ability to learn appropriate software
• Good English language and grammar skills
• Good presentation skills

• Global team environment
• Diverse experiences, backgrounds and perspectives valued
• Shared company values: Integrity, Intensity, Innovation and Involvement