Vishaleswaran Vijayasekaran, Experienced in Clinical Research documentation, regulatory submissions

About

I have 3 years of experience in Clinical Research, worked as Admin biostat & programming belongs to Inspection Readiness Team(IRT) in ICON clinical research, and my job role is to inspect the documents as per SOP compliance, supporting internal & FDA audits, Quality Control, reviewing deliverables each month, assisting study team on Quality standards of the documents & working with uploading document to TMF location like eTMF, etc.

Experience

Icon clinical research

Oct 2019 – Jun 2022

Chennai

Admin biostats & programming

1. To review each area of Biostat TMF in terms of completeness and compliance with the protocol, regulatory requirements, relevant SOP/WPs and study specific procedures & uploading to eTMF. 2. Reporting any non-conformance problems effectively and document the status of inspection readiness on each project. 3. Maintains contemporary IRT report and metrics for the department. 4. Cooperating with the project team and support to address non-compliance wherever required. 5. Assist the teams with the preparation during regulatory and sponsor inspections. 6. Preparation of documents on quality and inspect accuracy as per compliance process. 7. To create weekly status reports regarding review and share it with the senior management.

VS hospital

Apr 2019 – Oct 2019

Chennai

Clinical research coordinator

1.Reviewing the protocol, IB, ICF and evaluate subject eligibility, study timeline. 2.Preparing the necessary document for submission to IRB, sponsor. 3.Obtaining the signature from study team to documentation. 4.Managing the clinical trial by reviewing the CRF. 5.Maintaining the regular communication with Sponsor, CRO, IRB. 6.Coordinating with internal and other department and attend inbound calls.

Sathyam institute

Sep 2017 – Mar 2019

Chennai

Science faculty

Teaching Science subject for 9th, 10th standard. Teaching Biology for 11th, 12th Standard.

Education

Sathyabama University

Aug 2013 – Jul 2017

Btech, Biotechnology

Vishaleswaran Vijayasekaran

Experienced in Clinical Research documentation, regulatory submissions

Skills