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
To apply for this position, please visit
this Website.
Thank you,
BioTech FYI Center
http://biotech.fyicenter.com/