IQVIA
Clinical Research Associate I or II(m/w/x)
Vollzeit
mit Homeoffice
Junior
ab 3.600 / Monat
Wien
FR
FR 503221 g PPD Austria, LTD2 Tage
CRA II / Sr CRA - FSP(m/w/x)
Vollzeit
Remote
Junior
Keine Angabe
Wien
Nejo KI-Zusammenfassung
You will drive clinical trial integrity by managing site compliance and data accuracy. From conducting on-site visits to fostering site relationships, you'll ensure every study meets global standards.
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Anforderungen
- •Degree in life sciences, Nursing certification, or equivalent
- •One year clinical research experience or PPD Fellowship
- •Valid driver's license where applicable
- •Equivalent combination of education, training, or experience
- •Proven clinical monitoring skills
- •Medical terminology and therapeutic area knowledge
- •Knowledge of ICH GCPs and applicable regulations
- •Critical thinking and root cause analysis skills
- •Ability to manage Risk Based Monitoring
- •Good oral and written communication skills
- •Customer focus and active listening skills
- •Organizational and time management skills
- •Effective interpersonal skills
- •Attention to detail
- •Flexibility and adaptability
- •Ability to work independently or in teams
- •Good computer skills and Microsoft Office knowledge
- •Good English language and grammar skills
- •Good presentation skills
Bachelor-Abschluss
ODER
Abgeschlossene Berufsausbildung
Berufserfahrung
1 Jahr
Deine Aufgaben
- •Coordinate all clinical monitoring and site management
- •Conduct remote and on-site compliance visits
- •Manage diverse sponsor procedures and guidelines
- •Ensure adherence to ICH-GCP and SOPs
- •Maintain audit readiness and site relationships
- •Apply risk-based monitoring and root cause analysis
- •Verify data accuracy through SDR and SDV
- •Perform physical inventory of investigational products
- •Document observations in formal reports and letters
- •Escalate and resolve site deficiencies expeditiously
- •Maintain regular contact with investigative sites
- •Execute tasks per the approved monitoring plan
- •Participate in the investigator payment process
- •Collaborate with team members on finding resolutions
- •Attend and participate in investigator meetings
- •Identify and qualify potential investigators
- •Initiate clinical trial sites per regulatory obligations
- •Perform trial close-out and material retrieval
- •Manage essential document completion and filing
- •Conduct on-site file reviews per specifications
- •Provide status updates to the Clinical Team Manager
- •Update Clinical Trial Management Systems regularly
- •Facilitate communication between sites and project teams
- •Respond to regulatory audits and inspections
- •Complete expense reports and timesheets promptly
- •Assist with project publications and process improvements
Tools & Technologien
Microsoft Office
Sprachen
Englisch – verhandlungssicher
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens FR 503221 g PPD Austria, LTD erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
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