Clinical Research Associate II

• Perform and coordinate clinical monitoring and site management activities
• Conduct remote and on-site visits to assess protocol and regulatory compliance
• Manage sponsor-specific procedures and guidelines
• Ensure trials follow approved protocols, ICH-GCP guidelines, applicable regulations, and SOPs
• Protect subjects’ rights and well-being and ensure data reliability and 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 CRF review
• Assess investigational product inventory and records
• Prepare timely monitoring reports and letters
• Escalate deficiencies and follow issues through resolution
• Maintain contact with investigative sites between monitoring visits
• Participate in investigator meetings
• Identify potential investigators and initiate clinical trial sites
• Perform trial closeout and retrieve trial materials
• Ensure essential documents are complete and maintained
• Conduct on-site file reviews
• Provide trial status tracking and progress reports to the Clinical Team Manager
• Update clinical trial management systems according to study conventions
• Facilitate communication among investigative sites, the client company, and the PPD project team
• Respond to company, client, and regulatory audits and inspections
• Complete expense reports and timesheets
• Assist with project publications and tools
• Contribute to process-improvement initiatives

• Bachelor's degree in a life science related field, or Registered Nursing certification, or equivalent relevant formal academic/vocational qualification
• Approximately 2 years of experience as a clinical research monitor
• Valid driver's license
• 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, attention to detail, and ability to identify underlying issues
• Organizational and time management skills
• 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
• Ability to travel frequently, generally 60–80%, including possible extended overnight stays
• Ability to work in environments involving biological fluids and infectious organisms
• Ability to use required personal protective equipment, including protective eyewear, garments, and gloves

• Fully remote work mode
• Remote or on-site monitoring flexibility
• Opportunity to work with global pharmaceutical and biotechnology companies
• Frequent travel reimbursement implied through expense-report process