Clinical Research Associate II

• Perform and coordinate clinical monitoring and site management activities
• Conduct remote or on-site visits to assess protocol and regulatory compliance
• Manage required documentation, sponsor procedures and monitoring environments
• Ensure trials follow approved protocols, ICH-GCP guidelines, regulations and SOPs
• Maintain audit readiness and collaborative 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 case report form review
• Assess investigational product inventory and records
• Document observations in reports and letters and escalate deficiencies through resolution
• Maintain contact with investigative sites between visits to confirm protocol compliance and issue resolution
• 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 are complete and conduct on-site file reviews
• Provide trial status tracking and progress updates to the Clinical Team Manager
• Update study systems such as Clinical Trial Management Systems
• Facilitate communication among 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 to process improvement initiatives

• Bachelor's degree in a life sciences related field, or Registered Nursing certification or equivalent relevant formal academic/vocational qualification
• At least 1 year of experience as a clinical research monitor, or completion of PPD Drug Development Fellowship
• Valid driver's license where applicable
• Equivalency through appropriate education, training and/or directly related experience may be considered
• 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, including communication 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 as part of a team
• Solid knowledge of Microsoft Office and ability to learn appropriate software
• Good English language and grammar skills
• Good presentation skills

• Fully remote work mode
• Standard Monday–Friday work schedule
• Frequent travel generally 60–80%
• Potential extended overnight stays
• Personal protective equipment provided/required, including protective eyewear, garments and gloves