Clinical Research Assoc I Teva Pharmaceuticals BPharm / MSc
Job Description
Overseeing the smooth running of BA/BE studies.
Collecting, compiling, completing and reviewing data
obtained from research.
Informing participants about study during ICF process.
Get involved in the Investigational product administration
process.
To act as a custodian and monitoring of research
participants to ensure adherence to study rules.
Adhering to research regulatory standards and in-house SOPs.
Adhering to ethical standards like ICH-GCP and GLP.
Maintaining detailed records of studies as per FDA and other
required guidelines, including things such as drug administration and subject
specific case report forms.
Co-ordination with pathology laboratory regarding screening,
post study and follow up sample analysis.
Participating in subject enrolment efforts for new BA/BE
studies.
Ensuring that the necessary supplies and equipment for a
study are available before initiation of study.
Engaging with study staff for timely completion of study
documentation to meet stringent timelines of project submission.
Collects data as required by the protocol. Assures timely
completion of Case Report Forms.
Maintains study timelines.
Completes study documentation and maintains study files in
accordance with requirements
as per in house SOPs and procedures including, but
not limited to, consent forms, source documentation, case report forms and
investigational material accountability forms (if required).
Engaging with subjects and understanding their concerns.
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