Vekariya - Clinical Research - Ahmedabad, Gujarat, India

Nitesh Vekariya

Ahmedabad, Gujarat, India

Services

Clinical Research

Summary:

• Review study protocol and its attachments (i.e. ICF, CRF etc.) and communication with protocol writing group.
• Coordinate the movement of laboratory samples with vendor and sponsor.
• Monitoring the assigned BA/BE study as per company SOPs and in accordance with GCP and Regulatory requirement.
• Responsible for coordination with Principle Investigator for subject recruitment as per inclusion/exclusion criteria for particular trials.
• Review Medical Screening Record (MSR), Informed Consent Form (ICF) and completed CRFs within timeline.
• Responsible for to receive Investigational Products (IPs) from the sponsor, verification, dispensing and IPs accountability.
• Responsible for to monitoring online trial related activities (i.e. presentation of ICF, Dosing, Sample collection and shipment of biological sample to analytical facility etc.)
• Maintain Trial Master Files (TMF) including: ethics committee approvals; curricula vitae of investigators and study personnel; protocols; case report forms; consent documents; clinical trial material shipping orders; Clinical update etc.
• Participate in departmental planning sessions, and SOP development.

Work History

Junior Research Associate

Cliantha Research Limited India

From October 2013

Ahmedabad, Gujarat (October- 2013 to Present)
As a Junior Research Associate (Project coordinator) in BA/BE trials at Cliantha

Clinical Research Coordinator, Therapeutic area Cardiovascular and Diabetic

Research Limited India

February 2013 - September 2013

Ahmedabad (February-2013 to September-2013)


CURRENT JOB PROFILE
Review study protocol and its attachments (i.e. ICF, CRF etc.) and communication with protocol writing group.
Coordinate the movement of laboratory samples with vendor and sponsor.
Monitoring the assigned BA/BE study as per company SOPs and in accordance with
GCP and Regulatory requirement.
Responsible for coordination with Principle Investigator for subject recruitment as per
inclusion/exclusion criteria for particular trials.
Review Medical Screening Record (MSR), Informed Consent Form (ICF) and completed CRFs within timeline.
Responsible for to receive Investigational Products (IPs) from the sponsor, verification,
dispensing and IPs accountability.
Responsible for to monitoring online trial related activities (i.e. presentation of ICF,
Dosing, Sample collection and shipment of biological sample to analytical facility etc.)
Maintain Trial Master Files (TMF) including: ethics committee approvals; curricula
vitae of investigators and study personnel; protocols; case report forms; consent
documents; clinical trial material shipping orders; Clinical update etc.
Participate in departmental planning sessions, and SOP development.


PAST EXPERIENCES
As a Clinical Research Coordinator, Therapeutic area Cardiovascular and Diabetic

trainee CRC, therapeutic area Oncology

Malad (West)

July 2012 - October 2012

Mumbai. (July-2012 to October-2012)
Oversee the activities of multiple an oncology trials (Phase-II/III) during three months
training as a trainee CRC, therapeutic area Oncology at Hemato Oncology Clinic Pvt.

Patient Recruitment

January 2012 - March 2012

GCP training Certified.
HANDS OF EXPERIENCE AS A CLINICAL RESEARCH COORDINATOR
• Patient Screening and Study Document Maintenance.
• Patient Recruitment.
• Communicate with Sponsor.
• Assisting to manage Clinical Trial activity in the Hospital.
• Preparations of Investigator Site file (ISF) & Trial Master File (TMF).
• Preparation of Confidentiality Agreement, Feasibility Questionnaire, Study Synopsis,
study Protocol, Informed Consent Document & Case Report Form, and SOP.
• Assisting for Patient Randomization in ongoing Clinical Trials.
• Preparation of Regulatory Documents (i.e. FDA Form# 1572, 3455)
• Miscellaneous:
Monitoring that the research follows proper clinical practices and the maintenance of accurate protocol.
Verify that the documentation of the informed consent process for each study
subject is accurate and periodic.
See that all the adverse experiences are correctly reported and documented.
Check the completeness and accuracy of the case report.
Try to increase the uses and the efficiency of clinical documentation.

Qualifications & Certifications

Pharmacy

Rajeev Gandhi Technical University

Clinical

Imperial Institute of Clinical Research

Gujarat Secondary and Higher Education

Gujarat Secondary and Higher Education

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