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Sonu Singh
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Sonu Singh
Sonu Singh
Clinical Research Coordinator:
From Jan 2024 to till date working Senior Clinical Research Coordinator at Getwell Hospital & Research Institute (Pulmonary & Respiratory)
From Jul 2018 to Dec 2023, worked as Senior Clinical Research Coordinator at Midas Multispecialty Hospital Pvt Ltd, Nagpur(Gastroenterology)
From Jul 2017 to APR 2018 worked as Clinical Research Coordinator at Wockhardt Hospital ,Nagpur (Cardiologist)
From Apr 2016 to May 2017 Worked as clinical Research Coordinator at Sunil’s Diabetes Care n’ Research Centre, Nagpur (Diabetologist)
Total 7 year experience of Clinical Research
Experience in handling Global Clinical Trials for Multinational Companies.
Prepare site for new project initiation.
Prepare the site for qualification, selection, initiation and close out visits
Prepare the site for SIV
Help the investigator for budget negotiation.
Prepare the site for interim analysis
Sponsor CRO monitoring and Co-Monitoring
Handled Sponsor Audit internationally.
Enroll & Follow Up with
Assist in the ICF process, screening &
Data Collection and data entry in to eCRF in such a manner so that pharmacovigilance department has minimum chance to raise the
Prepare and maintain the Excel sheet for various
Coordinate subject follow up visits and prevent lost to follow
Maintain all the inventory/logistics accountability at
Assisting the site for monitoring & Audit
Reporting of SAE to Sponsor and EC reporting within specific time lines on behalf of PI .
Responsible for IP storage and its accountability at
Facilitating the communication between Site and
Good communication skill
Good analytical skills
Conduct site specific study feasibility
Conduct site qualification ,selection ,initiation and close out visit.
Conduct 2 Audit with International Sponsor.
Collate ethics committee documents / facilitate EC submission
Conduct CT in accordance with Regulations & Guidelines
Screen patient & Maintain patient screening log
Complete patient visits as per protocol requirements
Maintain site file to appropriate standard
IP storage accountability & Dispensing
Acknowledge receipt of IP to Warehouse
EDUCATION:
DEGREE/DIPLOMA
& YEAR AWARDED
COLLEGE/ INSTITUTE
BOARD/ UNIVERSITY
AREA OF STUDY
P.G.Diploma
AECRT,Getwell Hospital, Nagpur
Maharashtra Board
Clinical Research
Bsc( Graduate)Biochemistry
Hislop College,Nagpur
RTM university
Biochemistry
Training:
Completed RDC Data review, Discrepancy Management and Protocol Deviations training
Attended internal training & meetings
Trained on eCRF content & Data Entry [EDC-RAVE,imedidata,Inform oracle,] and sponsor provided platform
Trained on Clinphone,Phase Forward (I.R.T.) training for IWRS & IVRS
Trained on ICH- GCP,Investigator space platform, connect portal, IATA
Worked with vendor like Alimentiv(Robarts), Bioclinica, eCOA and ERT