I am working as a project coordinator in Veeda clinical research

Jigar V. Patel

M.Pharm (Pharmacology)

At Post- Ramana Muvada, Contact No:- +91-898*******

Ta- Mahudha, Email:- ********@*****.***

Dist- Kheda- 387335.

AREA OF INTEREST

Research and Development

Pre-clinical

Clinical

Pharmacovigilance

Regulatory Affaires

OBJECTIVE

I want to spend career in an extremely vibrant, stimulating and challenging work environment, where my analytical & technical ability get nourished.

I would like to become an active member of your organization that play a major role into public health improvement, as your organization is one of the leading organization in India.

WORK EXPERIENCE

24 Months of experience as project coordinator (Sr. research associate) at veeda clinical research

Job Responsibility:-

Review & finalization of study protocol, Inform consent document & Case report form. In addition to this preparation of the same if applicable.

Ensure approval letter from the IEC, No Objection Certificate (NOC) from regulatory authority, and availability of Investigational Product (IPs) at site before study execution.

Study Planning and Execution:

Coordinate with the Principal Investigator / Project Manager for planning of study schedule.

Prepare Trial master file as per the SOP or Sponsor’s requirement.

Prepare the protocol summary for the protocol training.

Ensure that the protocol training is provided to the concerned study personnel, before the start of study related activities.

Coordinate with screening team for subject recruitment and screening.

Coordinate with Dietician to ensure that the meal menu is prepared as per protocol requirements and submitted to caterer well in advance.

Ensure that all the volunteers reported for ICD presentation are fit for participation in the study as per the respective protocol.

Coordinate with Principal Investigator and / or Clinical Investigator and / or clinical research physician for ICD presentation to subjects

Coordinate with clinical staff for admission, discharge, Meal distribution, dosing/dosing supervision and monitoring the subjects during study for restriction compliance.

Ensure that the biological samples are collected, processed, stored and transferred as mentioned in the protocol. Review all forms and log formats related to the processing, storing and transferring of the samples.

Ensure that the adverse event/serious adverse event reported during the study are adequately handled.

Monitor the study to ensure that the study is conducted as per approved Protocol, International Conference on Harmonization-Good Clinical Practice (ICH-GCP) and in house Standard Operating Procedures (SOP).

Collect and review the raw data from group leaders (e.g. Nurse, Phlebotomist, CRP etc) and handover those to CQMs for their review.

Coordinate with the CQM for submission of raw data and draft project report to the QA department as per the predefine timeline.

Coordinate with the CQM and QA for audit reports and compilation.

Coordinate with Report writer and Project Manager for preparation of the final report.

Coordinate with the PI/CI and PM for submission of CRFs to the Data Management and resolve all the data queries, if applicable.

Identify protocol deviations, SOP deviations, file notes in consultation with the PI/CI/PM.

Coordinate with PM / Head CPU for preparation of new SOPs as well as revising current SOPs to upgrade the system.

Ensure the respective clinic/facility is ready for Regulatory/Client Audit or Visit & respond to their queries.

ACEDEMIC BACKGROUND

Course

Year of passing

Percentage/ CPI

Class

Board/ University

M. Pharm

JUNE 2014

6.8 CPI

First Class

GTU

B. Pharm

AUGUST 2011

68.00%

First Class

RGUHS

HSC

MARCH 2007

65.20%

First Class

GHSEB

SSC

MARCH 2005

61.14%

First Class

GSEB

COMPUTER KNOWLEDGE

Basic knowledge of MS

Internet application.

STRENGTH

Punctual

Positive Attitude

Work as a team member and as a team leader as per requirements.

PROJECT INVOLVEMENT

EVALUATION OF ANTIUROLITHIATIC ACTIVITY OF CHLOROPHYTUM BORIVILIANUM USING EXPERIMENTAL ANIMALS.

PERSONAL PROFILE

Date of Birth

21 April, 1990

Gender

Male

Nationality

Indian

Marital status

Unmarried

Languages Known

English, Hindi, Gujarati

Hobbies

Music, Sports, Travelling

DECLARATION

I hereby declare that the above mentioned information is true to the best of my knowledge.

I will try my level best to put all my work and effort for the well-being of the enterprise. I am disciplined and well adaptable to any of the situation.

Your’s faithfully

Jigar V. Patel

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