Clinical Research Associate

Location:	Kerak, Jordan, 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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