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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

To apply for this position, please visit this Website.

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