Company: inVentiv Health Clinical
Closing Date: 27 Dec 16
Salary (£): Negotiable
The Clinical Research Associate II performs routine site visits to ensure that the rights and well being of human subjects are protected; the reported trial data are accurate, complete, and verifiable from source documents; and that the conduct of the trial is in accordance with the currently approved protocol/amendment(s), SOPs, GCP/ICH Guidelines and other applicable regulatory requirements.
* Conduct site qualification, initiation, interim monitoring and study closeout visits for Phase 1-4 studies in accordance with federal regulations, Good Clinical Practices, ICH Guidelines, and Standard Operating Procedures and business processes.
* Conduct all clinical site activities according to the monitoring plan and in accordance with the study timelines and company objectives.
* Report monitoring activities and study site conduct accurately and completely.
* Prepare and submit written reports, both monitoring and administrative, in a timely, concise and objective manner.
* Input and maintain sudy information in tracking systems: Provide regular sites status updates to Monitoring Resources and Project Management Departments.
* Build relationships with current and potential investigators.
* Provide training and develop investigators/sites that are new to clinical research.
* Proactively identify issues that may impact enrollment and recruitment timelines.
* Collaborate with senior staff to develop initiatives and contingencies to ensure that timelines are met.
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