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 procedures and guidelines across different monitoring environments
• Ensure trials comply with 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 case report form review
• Assess investigational product inventory and records
• Document observations in reports and letters using approved business writing standards
• Escalate deficiencies and issues to clinical management and follow them through resolution
• Maintain contact with investigative sites between monitoring visits
• Conduct monitoring tasks according to the approved monitoring plan
• Participate in investigator payment processes
• Investigate and follow up on findings
• Participate in investigator meetings
• Identify potential investigators and support selection of qualified investigative sites
• Initiate clinical trial sites according to applicable procedures and regulatory obligations
• Perform trial closeout and retrieve trial materials
• Ensure essential documents are complete and maintained according to ICH-GCP and regulations
• Conduct on-site file reviews
• Track trial status and provide progress updates to the Clinical Team Manager
• Update study systems such as Clinical Trial Management Systems
• Facilitate communication among investigative sites, the client company and the project team
• Respond to company, client and regulatory requirements, audits and inspections
• Complete expense reports and timesheets
• Assist with project publications and tools
• Contribute ideas, process improvements and other project initiatives

• Bachelor's degree in a life sciences related field, or Registered Nursing certification or equivalent and 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 a combination of 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
• Customer focus, listening skills and attention to detail
• Organizational and time management skills
• Effective interpersonal skills
• Flexibility and adaptability
• Ability to work independently or in 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 work with potential exposure to biological fluids and infectious organisms
• Ability to use required personal protective equipment

• Fully remote work mode
• Standard Monday–Friday work schedule
• Frequent travel and site visits as part of the role
• Personal protective equipment such as protective eyewear, garments and gloves