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 clinical trial documentation and sponsor/monitoring-environment procedures
• Ensure trials follow approved protocols, ICH-GCP guidelines, applicable regulations, and SOPs
• 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 products through inventory and records review
• Document observations in reports and letters and escalate deficiencies through resolution
• Maintain contact with investigative sites between monitoring visits
• Participate in investigator payments, meetings, site initiation, trial closeout, and retrieval of 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 the Clinical Trial Management System
• Facilitate communication among investigative sites, the client company, and the project team
• Respond to company, client, and regulatory audits and inspections
• Complete expense reports and timesheets
• Contribute to project publications, tools, process improvements, and other 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
• 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
• Effective interpersonal skills
• Flexibility and adaptability
• Ability to work independently and 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
• Willingness and ability to travel frequently, generally 60–80%, including possible extended overnight stays
• Ability to work in office, laboratory, clinical, and/or home office environments
• Ability to use required personal protective equipment

• Fully remote work mode
• Standard Monday–Friday work schedule