US: Clinical Research Associate

[sqa...@yahoo.com]

US: Clinical Research Associate
To apply for this position, please visit this Website.
http://biotech.fyicenter.com/jobs/99887990_Clinical_Research_Associate.html
Date: 04-Feb-2014
To see other BioTech job opportunities, please visit http://biotech.fyicenter.com/

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


Thank you,
BioTech FYI Center
http://biotech.fyicenter.com/