CRA 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 sponsor-specific procedures
• Ensure trials comply with approved protocols, ICH-GCP guidelines, applicable regulations, and SOPs
• Protect subjects' rights and well-being and ensure data reliability
• Maintain audit readiness and collaborative relationships with investigational sites
• 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 as applicable
• 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 monitoring tasks according to approved monitoring plans
• Participate in investigator payment processes and investigator meetings
• Identify potential investigators and initiate clinical trial sites
• Perform trial closeout and retrieve trial materials
• Ensure essential documents are complete and conduct on-site file reviews
• Provide trial status tracking and progress reports to the Clinical Team Manager
• Update study systems such as 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 and contribute ideas
• 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
• Equivalency may be considered through a combination of appropriate education, training, and directly related experience
• 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
• Ability to communicate effectively with medical personnel
• Customer focus, listening skills, attention to detail, and ability to perceive underlying customer issues
• Organizational and time management skills
• Effective interpersonal skills
• Flexibility and adaptability
• Ability to work independently or as part of a team
• Good computer skills, including Microsoft Office 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
• Work-from-home environment
• Opportunity to work with a global team supporting pharmaceutical and biotech companies
• Professional collaboration and involvement in clinical research projects
• Personal protective equipment provided/required for applicable work conditions