Balaji Sridhar
Centralized Study Associate 2 at Fortrea | Clinical Trial Study Start up | ICF Customization | IRB submission | ICF Review | CT Essential documents
- Role
- Centralized Study Associate 2 at Fortrea
- Location
- Hyderabad, TG, IN
- LinkedIn followers
- 500 followers
About Balaji Sridhar
Clinical Research Professional with over 4 years of experience in global trial execution,…
Experience
Centralized Study Associate 2
May 2023 — Present · Bengaluru, IN
Perform or assist in the central IRB submissions (Advarra/WCG IRB’s) for the initial/amended trial documents (Amendments of Protocol, IB, ICF, and Subject recruitment materials), and submission of Continuing Review Report and Termination report. • Develop and/or review essential study documents (FDA 157 form, GP Letter, Patient Diary, Patient alert card, and Advertisement document) • Review initial/amended Core / Country / Site Informed Consent Forms (ICFs) • Develop and/or review patient recruitment materials in compliance with Sponsor requirements, local regulatory requirements and Good Clinical Practice (GCP) guidelines. • Maintain Study database (CTMS – Veeva) support study team in e-TMF management activities. • File required task-related documentation in the Electronic Trial Master File (eTMF)
Education
The Velammal International School
High School
2013 — 2015
Manipal Academy of Higher Education
Doctor of Pharmacy - PharmD
2015 — 2021
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