Senior Clinical Research Associate – FSP

🔥 17 minutes ago

🇭🇺 Hungary – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 12%

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

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 and on-site visits to assess protocol and regulatory compliance • Manage documentation, procedures, and sponsor or monitoring-environment guidelines • Ensure trials follow approved protocols, ICH-GCP guidelines, regulations, and SOPs • Monitor investigator sites using a risk-based monitoring approach • Apply root cause analysis and identify corrective/preventive actions • Ensure data accuracy through source document review, source data verification, and CRF review • Assess investigational products through inventory and records review • Document observations in reports and letters • Escalate deficiencies and follow issues through resolution • Maintain contact with investigative sites between monitoring visits • Conduct monitoring according to approved monitoring plans and participate in investigator payments • Provide trial-status tracking and progress updates to the Clinical Team Manager • Update and quality-check study systems, including CTMS • Participate in investigator meetings and identify/initiate qualified investigative sites • Support trial closeout and retrieval of trial materials • Ensure essential documents are complete and conduct on-site file reviews • Assist with project publications, tools, calls, newsletters, and other study tasks • Facilitate communication between investigative sites, the client, and the project team • Respond to audits, inspections, and regulatory requirements • Complete expense reports and timesheets • Contribute to process-improvement initiatives

🎯 Requirements

• Bachelor's degree in a life sciences related field, or Registered Nursing certification, or equivalent relevant formal academic/vocational qualification • 2+ years of experience as a clinical research monitor • Valid driver's license where applicable • Equivalent combination of appropriate education, training, and directly related experience may be considered • Effective clinical monitoring skills • Medical/therapeutic area knowledge and medical terminology • Understanding and application of ICH GCPs, applicable regulations, and procedural documents • Risk-based monitoring concepts and processes • Root cause analysis and problem-solving skills • Effective oral and written communication skills • Ability to communicate with medical personnel • Customer focus, listening skills, attention to detail, and ability to identify underlying issues • Interpersonal, organizational, and time management skills • Flexibility and adaptability • Ability to work independently or in a team • Proficiency in Microsoft Office and ability to learn appropriate software • Excellent Hungarian language and grammar skills • Good English language and grammar skills • Good presentation skills • Ability to lift 40 lbs. without assistance • Ability to comply with sponsor/client/site requirements, including possible vaccination-status or personal-information disclosure

🏖️ Benefits

• Fully remote work mode • Standard Monday–Friday work schedule • Remote and on-site work flexibility • Frequent travel expenses implied by required site travel • Personal protective equipment provided/required for applicable exposures

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