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| Company: |
Espoirbridge Recruiters |
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| Job Title: |
Clinical Research Associate |
| Job category: |
Pharmaceutical |
| Job Location: |
Berlin - Germany |
| Job Reference Number: |
96584654 |
| Job Description: |
Clinical Research Associate
Clinical Research Associates will carry out activities that may include investigational site selection, set up, initiation, monitoring and close-out as required by the Sponsor, whilst working to ICH-GCP, local regulations and company and/or Sponsor SOPs with appropriate levels of supervision and support.
Study Start-Up
• To conduct site selection visits.
• To co-ordinate essential documents for sites and investigators.
• To plan, coordinate, and conduct site initiation visits.
• To ensure that all contact (including written reports and follow up letters) generated for all aspects of the the pre-study and initiation contacts with investigators.
Monitoring
• To plan, coordinate, and conduct monitoring visits.
• To provide ongoing training of the site personnel regarding trial specific information and updates to industry standards.
• To collect data from clinical sites and work with Data Management to ensure timely resolution of data queries in order to achieve project deadlines.
• To ensure that supplies of study materials are maintained at designated sites .
• To ensure subject safety issues are identified and all Serious Adverse Events are reported. • To ensure all project tracking systems are maintained in order to track clinical trial subjects and data collection/review status within the clinical trial.
• To ensure ongoing reporting requirements for regulatory, ethical and local bodies are met for designated sites.
Study Close-Out
• To conduct close-out visits and collect all data and supplies from sites..
Requirements:
BSc in life science related field OR Registered Nurse is acceptable.
• Good organizational skills
• Excellent communication and interpersonal skills
• Good administrative and writing skills
• IT skills (e.g., Microsoft Office platform)
• Good knowledge of clinical research and clinical trial material development industry
• Proven experience of monitoring clinical trials to regulatory standards (i.e., ICH GCP)
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Skills Required:: |
Requirements:
BSc in life science related field OR Registered Nurse is acceptable.
• Good organizational skills
• Excellent communication and interpersonal skills
• Good administrative and writing skills
• IT skills (e.g., Microsoft Office platform)
• Good knowledge of clinical research and clinical trial material development industry
• Proven experience of monitoring clinical trials to regulatory standards (i.e., ICH GCP) |
Language Requirements: |
English-Good |
| Employment Type: |
Full Time |
| Yearly Salary: |
40000 GBP |
| Posting Date: |
2009-09-03 |
| Level of Education: |
Bachelor |
| Years of Work Experience: |
Less than 1 Year |
| Job also available in: |
There are several regional positions available in this project. Please apply for more information. |
| Company: |
Espoirbridge Recruiters |
| Contact Name: |
Espoirbridge Recruiters |
| Contact Phone: |
905 370 0192 |
| Preferred Method of Contact: |
No Preference |
| Preferred Language of Resume/Application: |
English |
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