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| Firma: |
Hays Pharma |
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| Job-Titel: |
Clinical Research Associate |
| Job Kategorie: |
Pharma/Biotech |
| Arbeitsort: |
Sofia - Bulgarien |
| Stellen-Beschreibung: |
The Clinical Research Associate performs routine site visits to ensure that the rights and well being of human subjects are protected; the reported trial data are accurate, complete, and verifiable from source documents; and that the conduct of the trial is in accordance with the currently approved protocol/amendment(s), SOPs, GCP/ICH Guidelines, and other applicable regulatory requirements.
-You would perform routine site visits, including pre-study, initiation, interim, and closeout visits. Visits to include monitoring of proper informed consent procedures, compliance with protocol, GCP/ICH Guidelines, and other applicable regulatory requirements, and assurance of good site performance. This is accomplished by detailed review of subject records, essential documents, investigational product disposition and accountability, site personnel and procedures
-You would manage assigned sites by regular contacts to ensure site compliance, adequate enrolment, and understanding of study requirements
-You would report to the project team, client, and site personnel any findings noted at monitoring visits. This is accomplished by completion of monitoring reports and follow-up letters within the project-specific timelines. Significant issues noted must be reported to appropriate personnel immediately
-Maintain Clinical or alternative project tracking system of subject and site information
-Participate in company-required training programs
-Perform necessary administrative functions (e.g., tracking of expense reports, time and attendance)
-Maintain home office (e.g., procurement of office supplies, submission of documents)
-Perform other duties as assigned
-You would perform necessary functions and as directed, any other duties commensurate with the post to ensure the smooth running of operations within the location(s).
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Sprachkenntnisse: |
Englisch-Sehr Gut |
| Beschäftigungsart: |
Vollzeit |
| Jahresgehalt: |
Keine Angabe |
| Eintragsdatum: |
2008-10-09 |
| Grad der Ausbildung: |
Studium |
| Ihre Erfahrung in Jahren: |
1 to 2 Years |
| Firma: |
Hays Pharma |
| Kontakt-Name: |
Hays Pharma |
| Kontakt-Telefon: |
07922874384 |
| Bevorzugte Kontaktmethode: |
E-mail |
| Preferred Language of Resume/Application: |
English |
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