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http://biotech.fyicenter.com/jobs/99895310_Clinical_Research_Associate.html
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Date: 13-Dec-2007
Clinical Research Associate II
Duties: Assists in the development of clinical trial protocols;
participates in the development of the overall clinical plan, drafts
protocols, and coordinates the protocol review and approval process,
to include submissions to regulatory agencies. Conducts clinical trial
site initiation visits; advises and trains site personnel on sponsor
and regulatory requirements for study conduct; participates and/or
conducts site meetings and multi-center investigator meetings and
prepares re****ts. Participates in the identification of potential
investigators and clinical sites, both nationally and internationally;
conducts pre-study site visits, collects and reviews data, and
prepares evaluative re****ts; participates in the final selection of
investigators and study sites. Conducts site monitoring visits and
follow-up to identify significant problems and issues and to ensure
that all clinical aspects of studies are being carried out in
accordance with state and federal regulations, guidelines and
policies. Ensures appropriate transmission of clinical case data to
the data management centers; reviews case re****t queries and problems,
and clarifies and/or obtains changes to data as appropriate. Assists
in the termination of clinical studies by identifying items and issues
for review and/or follow-up; assembles necessary do***ents, conducts
site termination visits to include test article reconciliation and
disposition, review of completeness and accuracy of files, and
retrieval of relevant codes and do***ents; prepares study termination
re****ts. Performs miscellaneous job-related duties as assigned.
Qualifications: BS/BA degree and 2-3 years CRA monitoring experience.
Requires specialized sup****t experience, office management skills,
basic accounting experience, knowledge of and experience with
computer, printers, fax and other automated office equipment. Requires
good computer skills, such as Word, Excel, PowerPoint and MS Office.
Preferred Skills: Self directed and takes initiative, highly
organized, able to coordinate multiple projects with maximum
efficiency, strong sense of personal responsibility for quality of
work including accuracy, reliability, completeness, timeliness and
presentation. Requires the ability to evaluate a given situation,
identification of issues and present observations and recommendations
to others.
Thank you,
BioTech FYI Center
http://biotech.fyicenter.com/
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