FSP CRA, Level II

• Perform and coordinate clinical monitoring and site management activities
• Conduct remote or on-site visits to assess protocol and regulatory compliance
• Manage required clinical trial documentation and procedures
• 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 case report form review
• Assess investigational product inventory and records
• Document observations in reports and letters and escalate deficiencies to clinical management
• Maintain contact with investigative sites between monitoring visits and follow up on issue resolution
• Conduct supervising tasks according to the approved monitoring plan
• Participate in investigator payment processes and investigator meetings
• Identify potential investigators and initiate clinical trial sites
• Perform trial closeout and retrieve trial materials
• Ensure crucial documents are complete and conduct on-site file reviews
• Provide trial status tracking and progress updates to the Clinical Team Manager
• Update 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 work and 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
• Understanding 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, attention to detail, and ability to perceive underlying issues
• Organizational and time management skills
• Interpersonal skills
• Flexibility and adaptability
• Ability to work in a team or independently
• Solid knowledge of Microsoft Office and ability to learn appropriate software
• Good English language and grammar skills
• Good presentation skills

• Competitive remuneration
• Annual incentive plan bonus
• Healthcare
• Employee benefits
• Career and development prospects
• Innovative, forward-thinking company culture
• Accessibility services/accommodations during the job application process for eligible job seekers with disabilities