Sr. CRA - IVD Experience - Virology - Fremont

Fremont  ‐ Onsite
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Keywords

Description

Duties:
  • Works under general supervision, and participates in the design, planning, implementation and overall direction of clinical research projects; May co-ordinate the activities of relevant colleagues within the Company and investigators to ensure compliance with the overall scientific study objectives. May work with international investigators and key customers as well.
  • Receives general instructions; plans and prepares studies.
  • Travels to field sites to monitor studies.
  • Reviews study protocols, reports and manuscripts. Contribute technical and clinical operations expertise for these documents
  • Monitors the sites and provides technical assistance, as necessary.
  • Works with Data Management and Biostatistical staff on the design of documents and processes for the collection of study data from participating sites.
  • Assists with the coordination of training and certification of study site personnel.
  • With guidance, ensures accurate and complete study management/data collection and transfer into the data management system.
  • Ensures site compliance with the study protocol, FDA regulations, ICH Guidelines and Good Clinical Practice (GCP)
  • Not an exhaustive list of duties


Experience Required:
  • 3-5 years of previous CRA work
  • IVD or medical device
  • field monitoring
  • Instrument data familiarity
  • Electronic Data Capture systems
  • Virology is preferred


To find out more about Real please visit www.realstaffing.com
Start date
03/2014
From
Real Staffing
Published at
13.03.2014
Project ID:
678417
Contract type
Freelance
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