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Monday, October 3, 2011

New discussion Seeking experienced Clinical Research Associates in California!!!

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  • Group: Job Openings, Job Leads and Job Connections!

Michelle Ettore (LION) has started a discussion: Seeking experienced Clinical Research Associates in California!!!

"Currently, one of our top clients is in search of an exceptional Clinical Research Associate located in San Francisco, CA. The role of the Clinical Research Associate (CRA) is to collaborate in the identification and drive the selection of investigator sites with input from other cross-functional groups. The CRA also monitors investigator sites in compliance with company SOPs, ICH/GCP, and local laws so that site performance targets are achieved. A few specific accountabilities: Conduct SCV and ensure clinical trials data are submitted to data management in a timely fashion Identify issues that may impact on the conduct of the study and ensure appropriate closure of all issues Proactively manage a greater investigator site workload commensurate with experience so that studies are run efficiently and key study objectives are met Ensure studies are run in line with ICH/GCP, local laws and company SOPs and procedures Ensure patient safety is maintained and all safety issues are reported correctly according to all relevant local and international regulatory requirements Inform the PI and site staff of all issues Agree and develop corrective and preventative actions with PI and site personnel to close all open issues Responsible for all aspects of site management from collaboration on site selection to study closeout Requirements: Bachelor's degree or higher in Life Sciences or Nursing 2+ years of regional monitoring is required Vaccine experience strongly preferred Must reside near a major airport Overnight travel up to 80-85% to neighboring states Full Driving License Computer literacy (word processing and spreadsheets) Knowledge of ICH/GCP, relevant international and local regulations relating to Clinical Research Demonstrated knowledge of quality and regulatory requirements across a range of different countries Demonstrated knowledge of clinical trial methodology and the drug development process, related to monitoring clinical trials, GCP, FDA, or country-specific regulatory environment Demonstrated success in prior scientific, technical, or administrative management roles Maintain knowledge and expertise on all relevant SOPs Ability to communicate effectively and appropriately with internal and external stakeholders Identifies and builds effective relationships with customers and other stakeholders Due to the precise requirements of this position, we will only be contacting candidates that meet all of the listed criteria. Cilck the link to apply or email me your resume directly to me at mettore2@kforce.com."

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