Clinical Research Associate – Multiple Levels

• 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 procedures
• 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 through physical inventory and records review
• 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 and investigator meetings
• Identify potential investigators and initiate clinical trial sites as needed
• Perform trial closeout and retrieval of trial materials
• Ensure essential documents are complete and compliant with ICH-GCP and applicable regulations
• Provide trial status tracking and progress updates
• Maintain complete and accurate study systems, including Clinical Trial Management Systems
• Facilitate communication between investigative sites, the client company and internal project teams
• Respond to company, client and regulatory requirements, audits and inspections
• Complete expense reports and timesheets
• Support project publications, tools and process-improvement initiatives
• Travel requirement higher than 75%

• Bachelor's degree in a life sciences related field
• At least 1 year of clinical monitoring experience in a clinical environment involving clinical trials, medical terminology, medical research, clinical research, health care, or a health sciences field with formal training in medical terminology and anatomy
• Equivalency through a combination of appropriate education, training and/or directly related experience may be considered
• 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
• Good interpersonal skills
• Customer focus, listening skills and attention to detail
• Good organizational and time management skills
• Flexibility and adaptability
• Critical thinking, root cause analysis and problem-solving skills
• Ability to manage Risk Based Monitoring concepts and processes
• Ability to work independently and in a team
• Solid knowledge of Microsoft Office and ability to learn appropriate software
• Good English and Polish language and grammar skills

• Competitive salary
• Extensive benefits package focused on employee health and well-being
• Flexible working culture
• Work-life balance
• Award-winning learning and development programme
• Collaborative environment
• Professional and personal growth opportunities