Monitoring of outsourced clinical BA BE studies at external CROs as per protocol & applicable regulatory guidelines
To Coordinate with external CRO representative for technical discussion & study Update.
To review TMF , screening MSR, ICD, period CRFs , dosing, sample collection, sample processing etc during monitoring visit.
Planning, execution & supervision of inhouse BA BE studies as a clinical research coordinator.
To Coordinate inhouse BA BE studies starting from protcol training , TMF Compilation , study planning, preparation of study updates, resolution of study queries.
To ensure proper raw data documentation during the clinical study phases.
Work Experience
3-5 years of relevant experience.
Education
Masters in Pharmacy
Competencies Skills Required crfs
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Research Associate • Pune, India
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