Clinical
Research Associate @ Sami Labs Limited
Job Description
Handling study/sponsor specific software's like CTMS (Clinical
Trail Management System), VTMF (VirtualTrial Master File) & Medidata Rave
for EDC.
* Providing guidance for Addressing Compliance Issues.
* Ensure that all safety information and all trial-related
medical decisions are reviewed and documented by a qualified study physician who is an investigator or
sub-investigator for subjects assigned to 100% SDV
* Perform detailed monitoring visits and source data
verification & writing Monitoring Visit Reports
* Electronic Data transfer, Query Resolution and perform
remote monitoring.
* Regulatory Document Review (Trial Centre File) - review of
the TCF & Confirm the availability of current IRB/EC and HA submissions/approvals (including SUA
submissions), as well as the receipt of critical communications (eg. safety updates).
* Source Document Verification & Check that all central
laboratory reports are being signed off timely by the investigator for subjects.
* Adjudication package preparation & Reconciliation
process.
* Ensure study drug accountability
Education-
UG:B.Pharma - Pharmacy, BAMS - Ayurveda, B.Sc - Any
Specialization, Bio-Chemistry, Chemistry
PG:MS/M.Sc(Science) - Chemistry, Bio-Chemistry, Biotechnology,
M.Pharma - Pharmacy
Doctorate:Ph.D - Chemistry, Bio-Chemistry/Bio-Technology,
Biotechnology
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