Huma Hashmi

Working as Clinical Trial Associate with good knowledge of :-

Site Investigator Payment Management
Vendor Payment Management
Ethics Submissions 
Site Initiation Activity
Close Out Activity
TMF and SMF Reconciliation 
Passthrough Study Expense Reconciliation
DocuSign and Adobe : Electronic signature processing
Adherence to ICH GCP, NDCT rules 2019 and GDP
ALCO ++ 
Veeva Vault eTMF
CTMS

Awarded as “Team Player” achievers award at current organization.
Achieved Gold Medal and stayed University Topper in Master’s and was awarded by Honorable
President Shri Pranab Mukherjee.
Achieved Gold Medal in Bachelors (Botany & Chemistry).

June 2022-Present

 Tech Observer India Pvt Ltd

Clinical Trial Associate

• Managed site investigator payment coordination, reviewed invoices, and liaised with CRAs for payment processing. 
• Oversaw vendor payment management, including equipment procurement, invoice collection, and reconciliation.
•  Prepared Ethics Committee (EC) dossiers and ensured compliance with study protocols. Evaluated potential clinical sites based on various criteria for trial conduct feasibility.
•  Conducted site initiation activities, prepared ISF binders, and tracked required documents. Accompanied CRAs during monitoring visits, verified patient data, and conducted ISF reviews. 
• Managed closeout activities, ensured all payments were made, and collected study documents. 
• Conducted TMF and SMF reconciliation, collected and reviewed studyrelated documents. Reconciled passthrough study expenses, tracked payment processes, and updated records. 
• Contributed to the development and improvement of standard operating procedures (SOPs) related to site management and document handling.
•  Prepared and maintained study-specific reports, trackers, and metrics for management review and decision-making 
• Processed electronic signatures for various documents using DocuSign.

Sep 2015-Dec 2015 

 Excel Life Sciences

CRC Trainee

• Preparation and review of Project Master Files (PMF) and Site Master Files (SMFs)
•  Preparation of Ethics Committee Dossiers for amendment of Protocols, Investigator's Brochure Preparation of SOPs and Preparation of Feasibility Questionnaires and maintaining trackers for it Preparation of other study materials These study materials include, but are not limited to, the informed consent document, case report forms (CRFs), enrollment logs, and drug/device accountability logs
•  Establishes and organizes study files, including but not limited to, regulatory binders, study specific source documentation and other materials

 ·

2015

Masters in Biochemistry

Jamia Millia Islamia