Clinical Research Associate I/II

• Perform and coordinate clinical monitoring and site management activities
• Conduct remote and 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, 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 SDR, SDV and CRF review during on-site and remote monitoring
• 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 approved monitoring plans
• Participate in investigator payment processes and investigator meetings
• Identify potential investigators with client companies
• Initiate clinical trial sites and ensure protocol, regulatory and ICH-GCP compliance
• Perform trial closeout and retrieve trial materials
• Ensure essential documents are complete and maintained according to ICH-GCP and applicable regulations
• Conduct on-site file reviews
• Track trial status and provide progress updates
• Maintain accurate and current study systems, including Clinical Trial Management Systems
• Facilitate communication among investigative sites, client companies and internal project teams
• Respond to company, client and regulatory requirements, audits and inspections
• Complete expense reports, timesheets and other administrative tasks
• Assist with project publications and tools
• Share ideas and contribute to project work and process-improvement initiatives

• Bachelor's degree in a life sciences related field, or Registered Nursing certification, or equivalent and relevant formal academic/vocational qualification
• Minimal clinical monitoring experience comparable to 2 years in a clinical environment, including clinical trials, medical terminology, medical research, clinical research, health care, or a health sciences field with formal training in medical terminology and anatomy
• Monitoring experience with Oncology
• Valid driver's license where applicable
• Equivalency through a combination of appropriate education, training and/or directly related experience may be considered
• 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 and Polish language and grammar skills
• Frequent driving to site locations and frequent travel, generally 60-80%, potentially including extended overnight stays
• Ability to work with exposure to biological fluids, infectious organisms, electrical office equipment and fluctuating/extreme temperatures on rare occasions
• Ability to use required personal protective equipment, including protective eyewear, garments and gloves

• Fully remote work arrangement
• Full-time employment
• Standard Monday-Friday work schedule