Sami Labs CRA Job Vacancy – Pharma Candidates Apply
Sami Labs Bengaluru is hiring for the post of Clinical Research Associate – Pharma Candidates looking for a CRA job can apply for this post via online application. Interested candidates should apply online via the link given below –
Job Title: Clinical Research Associate
Eligibility: B Pharma, M Pharma
Experience: 3 – 7 Years
Location: Bengaluru
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
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