Senior Clinical Research Associate - FSP

🕒 vor 27 Tagen

🇭🇺 Ungarn – Remote

⏰ Vollzeit

🟠 Senior

🧪 Wissenschaftler Klinische Forschung

👻 Geisterscore 21%

Was es bedeutet: wie wahrscheinlich diese Stelle offen bleibt, ohne dass aktiv eingestellt wird.So liest du es: 60 % oder höher heißt, wir halten das für einen Geisterjob. Niedrigere Werte sind weniger bedenklich.Wie wir werten: Dauer offen, Neuveröffentlichungen, offene Stellen vs Teamgröße, wie schnell Stellen geschlossen werden, und ob ein Gehalt angegeben ist.Hinweis: eine Schätzung aus öffentlichen Daten, kein Urteil über das Unternehmen. Echte Stellen können hoch punkten, nutze es also als Hinweis, nicht als Fakt.

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Thermo Fisher Scientific

WebsiteLinkedInAlle Stellen

10.000+ Mitarbeiter

Gegründet 1956

🏥 Gesundheitswesen

📦 Logistik

🏭 Fertigung

Healthcare • Logistics • Manufacturing

Thermo Fisher Scientific ist der weltweite Marktführer im Dienste der Wissenschaft mit einem Jahresumsatz von mehr als 40 Milliarden US‑Dollar. Ihre Mission ist es, Kunden dabei zu unterstützen, die Welt gesünder, sauberer und sicherer zu machen – indem sie die lebenswissenschaftliche Forschung vorantreiben, komplexe analytische Herausforderungen lösen, die Produktivität in Laboren steigern und die Gesundheit von Patienten durch Diagnostik sowie die Entwicklung lebensverändernder Therapien verbessern. Mit einem globalen Team bietet das Unternehmen innovative Technologien und pharmazeutische Dienstleistungen über Marken wie Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon und PPD.

Beschreibung

• Perform and coordinate all aspects of clinical monitoring and site management • Conduct remote or on-site visits to assess protocol and regulatory compliance and manage required documentation • Manage procedures and guidelines from different sponsors and monitoring environments • Ensure trials follow approved protocols, ICH-GCP guidelines, applicable regulations, and SOPs • Ensure subjects' rights, well-being, 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 SDR, SDV, and CRF review during on-site and remote monitoring • 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 to confirm protocol adherence, issue resolution, and timely data recording • Conduct monitoring tasks according to the approved monitoring plan • Participate in investigator payment processes and investigator meetings • Track trial status and provide progress updates to the Clinical Team Manager • Update study systems, including CTMS, and perform required CTMS report quality-control checks • Identify potential investigators and initiate clinical trial sites according to relevant procedures • Ensure trial closeout and retrieval of trial materials • Ensure essential documents are complete and conduct on-site file reviews • Assist with project publications/tools and contribute ideas to project teams • Perform additional study tasks assigned by the CTM, such as trip report review, newsletter creation, and leading CRA team calls • Facilitate communication among investigative sites, the client company, and the PPD project team • Respond to company, client, and regulatory requirements, audits, and inspections • Complete administrative tasks such as expense reports and timesheets • Contribute to process improvement initiatives and other project work

🎯 Anforderungen

• 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 or comparable experience • Valid driver's license where applicable • Equivalency may be considered through a combination of appropriate education, training, and/or directly related experience • Effective clinical monitoring skills • Understanding of medical/therapeutic area knowledge and medical terminology • Demonstrated application of ICH GCPs, applicable regulations, and procedural documents • Critical thinking, root cause analysis, and problem-solving skills • Ability to manage Risk Based Monitoring concepts and processes • Effective oral and written communication skills, including communication with medical personnel • Customer focus, listening skills, attention to detail, and ability to identify underlying issues • Effective interpersonal, organizational, and time management skills • Ability to work flexibly, adaptably, independently, and as part of 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 disclosure of vaccination status or other personal information • Ability to travel frequently, generally 60–80%, including possible extended overnight stays • Ability to work with potential exposure to biological fluids and infectious organisms and use required personal protective equipment

🏖️ Vorteile

• Fully remote work arrangement • Full-time employment • Standard Monday–Friday work schedule • Frequent travel expenses associated with site visits • Professional collaboration and project/process improvement opportunities