FSP Clinical Research Associate I/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 required clinical trial documentation and sponsor-specific procedures and guidelines
• Ensure trials follow approved protocols, ICH-GCP guidelines, applicable regulations, and SOPs
• Protect subjects' rights and well-being and ensure data reliability and audit readiness
• Develop collaborative relationships with investigational sites
• Monitor investigator sites using risk-based monitoring, root cause analysis, critical thinking, and problem-solving
• Ensure data accuracy through source document review, source data verification, and CRF review
• 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 according to approved monitoring plans and participate in investigator payment processes
• Participate in investigator meetings and help identify qualified investigators and sites
• Initiate clinical trial sites and perform trial close-out and retrieval of trial materials
• Ensure essential documents are complete and conduct on-site file reviews
• Track trial status, provide progress reports, and maintain study systems such as CTMS
• Facilitate communication among investigative sites, the client company, and internal project teams
• Respond to company, client, and regulatory requirements, audits, and inspections
• Complete expense reports and timesheets
• Assist with project publications and 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
• Approximately 2 years of clinical monitoring experience in a clinical environment, 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
• Working knowledge of ICH GCPs, applicable regulations, and procedural documents, or ability to attain and maintain it
• Good oral and written communication skills
• Good interpersonal skills
• Customer focus, listening skills, attention to detail, and ability to identify underlying customer issues
• 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 or as part of a team
• Solid knowledge of Microsoft Office and ability to learn appropriate software
• Good English and Polish language and grammar skills
• Ability to travel frequently, generally 60–80%, including potential extended overnight stays
• Ability to work in office, laboratory, clinical, and/or home office environments and use required personal protective equipment

• Fully remote work mode
• Standard Monday–Friday work schedule
• Opportunity to work with global teams and leading pharmaceutical and biotechnology companies
• Professional exposure to clinical trials across multiple sponsors and monitoring environments
• Personal protective equipment provided/required for applicable work environments