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US: Clinical Research Associate

Date: 04-Feb-2014
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Clinical Research Associate

Build relationships with investigators and site staff Participate in Investigator and other external or internal meetings as required Arrange on-site visits and logistics (e.g. travel arrangements) Perform on site visits and generate visit/contact reports in accordance with the monitoring plan Perform site facilities inspection Monitor patient safety on-site (review for missing SAEs, AEs, ConMed) and address protocol violations Responsible for the completeness and quality of the on-site files Respond to site issues alerted by the project team (i.e., non-responsive site, Protocol Deviations concerns, quality issues etc., items that require face to face interaction) Collect SRP documents during site visits as needed Establish site recruitment plan in collaboration with site during Qualification Visit; follow-up and update at Initiation Visit and Monitoring Visit Update all relevant tracking system on an on-going basis Code and scan Central File documents where applicable Ship relevant wet-ink signature documents to the Assistant or back to the site

Inform responsible CRA Coordinator/COL/Manager of work status regularly Complete routine administrative tasks in a timely manner (e.g. timesheets, metrics, travel expense claims) Perform co-monitoring visits with less experienced CRAs or at problem sites as required Function as mentor and role model for less experienced CRAs and/or team members to ensure study specific training

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BioTech FYI Center