Clinical Research Associate, Level II and above

• Perform and coordinate clinical monitoring and site management activities
• 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 data review, source data verification, and CRF review during on-site and remote monitoring
• Assess investigational product inventory and records
• Document observations in reports and letters and escalate deficiencies through resolution
• Maintain contact with investigative sites between monitoring visits
• Conduct monitoring tasks according to the approved monitoring plan
• Participate in investigator payments and investigator meetings
• Identify potential investigators and initiate clinical trial sites
• Perform trial closeout and retrieval of trial materials
• Ensure essential documents are complete and conduct on-site file reviews
• Track trial status and provide progress updates; maintain complete and accurate study systems such as CTMS
• Facilitate communication among investigative sites, client companies, and internal project teams
• Respond to company, client, and regulatory requirements, audits, and inspections
• Complete expense reports and timesheets
• Assist with project publications/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 2 years of independent clinical monitoring experience in a clinical environment, or comparable experience in clinical trials, medical terminology, medical research, clinical research, health care, or a health sciences field with formal training in medical terminology and anatomy
• Valid driver's license where applicable
• Basic medical/therapeutic area knowledge and understanding of medical terminology
• Ability to attain and maintain working knowledge of ICH GCPs, applicable regulations, and procedural documents
• Good oral and written communication skills, including effective communication with medical personnel
• Good interpersonal skills
• Customer focus, listening skills, attention to detail, and ability to perceive underlying customer issues
• Good organizational and time management skills
• Flexibility and adaptability
• Well-developed critical thinking, root cause analysis, and problem-solving skills
• Ability to manage risk-based monitoring concepts and processes
• 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

• Fully remote work mode
• Standard Monday–Friday work schedule
• Personal protective equipment provided/required, including protective eyewear, garments and gloves