US-MD-Gaithersburg: Senior Clinical Scientist
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Date: 24-Nov-2009
Senior Clinical Scientist
? Assist the Medical/Clinical Research personnel to: o Medical
monitoring of trials ? Site interaction with documentation ? Regard I/
E criteria and other protocol related issues ? Medical Questions ?
Unblinding requests ? Safety issues o Data Review ? Safety • Serious
Adverse Events (SAEs) • Blinded Safety Review • Council for
International Organizations of Medical Sciences (CIOMS) Review •
Narrate Reviews • OSMB responsibilities o Organize, Participate in •
Study set-up • Investigator meetings
o Establish and approve scientific methods for design and
implementation of applicable clinical protocols, data collection
systems, and final reports. o Develop and review key documents to
support the components of a regulatory submission. o Review and
interpret study results as appropriate. o Prepare clinical
publications or provide input into communication and publication
development. ? Become familiar with the latest thinking regarding
mechanism of disease, diagnostic tests, treatment, drug development
trends, and regulatory requirements in assigned disease and
therapeutic areas.
Thank you,
BioTech FYI Center
http://biotech.fyicenter.com/