FSP 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 required documentation and ensure audit readiness
• 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
• Conduct supervising tasks according to the approved monitoring plan
• Participate in investigator payment processes and issue resolution
• Participate in investigator meetings and identify potential investigators
• Initiate clinical trial sites and perform trial closeout and retrieval of trial materials
• Ensure crucial documents are complete according to ICH-GCP and applicable regulations
• 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 among 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 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
• 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 independently or in a team
• Digital literacy, including Microsoft Office and ability to learn appropriate software
• Good English language and grammar skills
• Good presentation skills

• Annual incentive plan bonus
• Healthcare
• Employee benefits
• Career and development prospects
• Innovative, forward-thinking company culture