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Central point of communication between client and investigators for all clinical trial related activities to assure trials are conducted on time and budget, while fully GCP, ICH and client SOP compliant We are global leaders in the recruitment of specialists for permanent employment. We are looking for a Clinical Research Associate (m/f) for a permanent position in Bern region Reference number: 170464/11 Your Duties:
- Central point of communication between client and investigators for all clinical trial related activities to assure trials are conducted on time and budget, while fully GCP, ICH and client SOP compliant
- Participate in site nomination process, perform evaluation of site capability and make recommendation for inclusion in clinical trial
- Prepare and collect site level regulatory documents required for submission to ethics committees, health authority and initial study drug release; resolve problems to ensure compliance
- Execute site initiation and training activities
- Practise total site management including onsite and remote monitoring visits according to monitoring plan
- Resolve site level update of technical systems (Trial Management Systems, Electronic Data Capture)
- Manage recruitment implementing appropriate contingency plans as needed
- Assure continual GCP, ICH and client SOP compliance (Informed Consent process, Source Data Verification, Adverse Event and Serious Adverse Event reporting, Investigator Notifications, protocol, drug accountability etc.)
- Perform data query resolution process (both at site and with Data Management)
- Assist study sites and local study team in preparation activities for audits and inspections
- May act as local (or global) CRA Lead, as assigned
Your Qualifications:
- University degree in biology, biochemistry, pharmacology or related life science disciplines
- Fluency in written and spoken German and English, and advanced in French or fluency in written and spoken French and English, and advanced in German
- Italian skills are an asset
- Good experience in clinical operations or having demonstrated adequate level of proficiency within the CRA competency profile
- Understands and can apply knowledge of clinical trial designs to trial execution
- Knowledge and experience in international standards (GCP/ICH), international (FDA, EMEA) and local (Swissmedic) regulations
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