| Job Title: Clinical Research Associate; Respiratory |
| Description |
You would join a rapidly expanding global Clinical Research Organisation. They require an experienced CRA to support their work in Poland. Ideally you will be an experienced CRA.- Assist in the set-up of trials which may involve undertaking training by the Sponsor company
- Assist, if required, with the design of specific trial materials
- Ensure that the contractual documents between the centres, Sponsor companies and/or our Company are complete and in order
- Undertake site visits at intervals specified by the trial Sponsor
- Maintain regular remote contact with the centres to ensure the smooth operation of the trial
- Provide any reports that may be requested by the Sponsor Company
- Maintain and update correspondence and other documentation for the trial master file and investigational site files to ensure an adequate and organised audit trail
- Participate with the Sponsor Company with any trial visits or audits which they may wish to carry out
- Assist if required with the review and amendments of the Company SOPs
- Understand the Company's Data Entry System sufficiently so as to interface with the trial website and relevant databases in order to obtain progress reports on the centres, for which the jobholder is responsible, in order to organise their monitoring activities more effectively
- Ensure that all duties are undertaken in accordance with Good Clinical Practice (GCP) guidelines, relevant national and supranational legislation, SOPs and any relevant trial-specific SOPs or operational manuals. Furthermore, the SOPs of the Sponsor company/contractor must be adhered to where provided.
Requirements- Respiratory experience
- Previous clinical trial monitoring experience
- Strong understanding of ICH GCP and FDA requirements
- Clean driving license and prepared for overnight absences
- Fluent in Polish and English
- Life science or Nursing degree.
Please note that only candidates with EU work authorisation will be considered. |
| Details |
| Post Date: |
06/11/2009 |
| Hours: |
Full Time |
| Location: |
Poland |
| Working Term: |
Permanent Position |
| Salary: |
On application |
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