Clinical Research Associate – Multiple Levels

🔥 16 minutes ago

🇵🇱 Poland – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧪 Clinical Research

🗣️🇵🇱 Polish Required

Where this job comes from

Posted on Thermo Fisher Scientific's careers page, not through a job board

First seen by Remote Rocketship 16 minutes ago

Logo of Thermo Fisher Scientific

Thermo Fisher Scientific

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

🏥 Healthcare

Biotechnology • Pharmaceuticals • Healthcare

Thermo Fisher Scientific is the world leader in serving science, with a stated mission to enable customers to make the world healthier, cleaner and safer. The company provides a broad portfolio of laboratory instruments, analytical technologies, diagnostics, consumables, software and services that support life‑sciences research, analytical testing, clinical diagnostics and the development and manufacture of therapies. Its operations and offerings (as described on its site and in its news) include advanced imaging and electron microscopes, chromatography and mass‑spectrometry systems, genetic and clinical testing, lab automation and AI tools, bioprocessing and contract development/manufacturing services (brands cited include Thermo Scientific, Applied Biosystems, Invitrogen, Gibco, Fisher Scientific, Unity Lab Services, Patheon and PPD). Thermo Fisher reports annual revenue over $45 billion and emphasizes corporate social responsibility, environmental and community programs alongside its scientific products and services.

📋 Description

• 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%

🎯 Requirements

• 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

🏖️ Benefits

• 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

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