Engage in
company training program to gain knowledge and skills required to
independently contact investigative sites and participate in clinical
research. Collect, compile, document and support clinical research data
via remote site monitoring. May be responsible for the remote monitoring
of multiple projects.
RESPONSIBILITIES
Complete appropriate therapeutic, protocol and clinical research training to perform job duties.
Under
close supervision, collect, track and review study site critical
documents used to monitor interest for enrollment of investigative
sites.
Document
and track all communication (email, voice, fax, call reports) with study
site personnel and client interactions, in accordance with study plans.
Under
close supervision, coordinate site recruitment and enrollment efforts.
Ensure the site is recording data from patient charts, medical records,
interviews, questionnaires, diagnostic tests and other sources in
accordance with study plans.
Follow
established guidelines in the collection and tracking of clinical data
and resolution of data queries in accordance with study plans and client
preferences. Under close supervision, evaluate and assure quality of
data collected; ensure that all data and study documents are handled
consistently with the demands of regulatory agencies with respect to
data protection.
Assist the
clinical team in the filing and archiving of clinical documentation
according to the scope of work and standard operating procedures. Assist
with periodic review of study files for accuracy and completeness.
Under
close supervision, monitor site and subject progress, including
documentation and reporting of adverse events; identify and escalate
need for corrective actions to line manager as appropriate.
Under close supervision, may respond to questions on study procedures/protocol via the study hotline.
Perform on-site co-monitoring and remote monitoring activities as needed or other duties, as assigned.
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