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Clinical Research Associate

Location:Cairo, Egypt, Middle East
Job Type:Permanent
Posted:7th Aug 2008
Closing Date:4th Sep 2008
Posted By:espoirbridge
Details:
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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