MRS. GAURI ROHAN SHETKE

797-***-****/976-***-****

adn7ep@r.postjobfree.com

CARRER OBJECTIVE

To work in a challenging profession where I can positively contribute towards the growth of the organization and grow as an individual.

SYNOPSIS

A competent professional with experience in Clinical Research with good knowledge of ICH - GCP, USFDA, EMEA, CDSCO and Schedule Y.

Acquired practical knowledge through various trainings and academic projects.

PROFESSIONAL EXPIRENCE

Advanced Centre for Treatment, Research and Education in Cancer, Kharghar

July 2016 to Till this date

Designation: Sr.Research Co-Ordinator

Screening and enrolling subjects in studies and managing their participation according to ethical, regulatory, Institution SOP and protocol-specific requirements. Documenting and assuring that the Consent process has been done before performing any study related procedures.

Ensure study actives performing according to ethical, regulatory, Institution SOP and protocol-specific requirements.

Developing organizational aids and check lists to facilitate patient recruitment and the collection of complete and accurate study data.

Maintaining TMF files for each research project.Communicating with the IEC/IRB as appropriate.

Reporting Serious Adverse Events to the concerned regulatory authorities.Participating in audit preparation activities.

Prepared eCRF and accurate data entry in RedCap.

Accurate and timely data entry in SPSS .

Perform project completion and involved in analysis part of the project.

Tracking timely payments to investigators and vendors.

Overall project management from start to end activity of project.

TATA MEMORIAL HOSPITAL,Kharghar

CANCER CENTER FOR EPIDEMIOLOGY,

March 2015 ToJuly 2016

Designation: Research Co-Ordinator

Abstract data from cancer patient file for hospital based cancer registry.

Work on Patterns Of Care And Survival Studies.

To enter quality data for head & neck, breast & cervix cancer including clinical trial cases in POCSS.

In that contain identifying demographic & diagnostic information using ICD 10,details of stage,treatment details.

Generate Data For Statistical Analysis.

To generate reliable data on the magnitude and patterns of cancer.

Panexcell Clinical Lab Private Limited

October 2014 TO March 2015

Designation: OFFICER – QC

To monitor the clinical phase of BA/BE studies in compliance with ICH-GCP, GLP,SOPs and applicable regulatory guidelines and within timelines.

To write and revise SOPs as per need and ensure Implementation.

To impart GCP and other technical training to the personnel SOPs and applicable procedures identified.

To supervise BE Project acitivity and co-ordinate with other department till completion asper committed timelines and oversee the project documentation, complication and archiving of repots, raw data and SOPs.

To perform audits of external service such as a accredited pathology and X-Ray laboratory in

accordance to compliance with ICH-GCP, SOPs and applicable and local Regulatory guidelines and within timelines.

Collect and review essential documents from CRA

Additionally monitoring activities of personnel responsible for assigned job.

To verify project related document (CRF, MSR, ICD, Logbooks, TMF) in compliance with ICH-GCP, GLP, SOPs &applicable Regulatory Authority.

April 2010 TODecember 2011

In RaptimResearch LTD. as a Technical Officer.

To verify project related document (CRF, MSR, ICD, Logbooks, TMF) in compliance with ICH-GCP, GLP, SOPs AND applicable Regulatory Authority

Monitor the conduct of clinical trials, especially enrollment and quality of data.

Preparation of TMF files.

Dispensing of formulation for BA/BE study.

Preparation of pre-study information sheet for study announcement.

Handling and retention of formulation sample (clinical supplies) received from the sponsor for

a proposed BA/BE study and maintaining records for same.

To ensure that the study related activities are performed in compliance with the ICH-GCP

guidelines, Helsinki declaration and protocol.

Checking calibration record of pipette, HPLC,LC-MS, Analytical balance, pH meter &

preparation of Master schedule plan of calibration.

Preparation for sponsor & regulatory audit.

Ensure final tracking, documentation and reconciliation of all clinical supplies is complete for the study.

NOV 2004 TONOV 2007

As a Lecturer in Sawakar Pharmacy College, Satara.

EDUCATIONAL ATTAINMENTS

M. Pharm.

Quality Assurance (First Class)

College of Pharmacy, Medha.

ShivajiUniversity, Maharashtra.(2014)

M. Pharm. Research topic: “Quality Assurance in Bioanalytical to Comply Global Regulatory Requirement.”

Contents of thesis:

Bioanalytical method validation, Incurred sample reanalysis, Subject analysis as per USFDA,ANVISA,EMA.

Post Graduate Diploma In Clinical Research & CDM

NEXUS-CRI,(2012)

January 2012 To April 2012

B. Pharm.

Sinhgad College Of Pharmacy, Pune, Maharashtra (2004)

HSC

Kolhapur Board, Maharashtra (2000)

SSC

Kolhapur Board, Maharashtra (1998)

COMPUTER SKILLS:

MSCIT Qualified

WORKSHOP ATTENDED&INDUSTRIAL TRAINING

OkasaPharma, Satara-One month training in 2004

Participated & completed the Clinical Data Management project for “Acute Non Specific Low Back Pain Study For DCGI Submission.”2012

July 2013 To January 2014 Project Trainee at Accutest Research Laboratories (I) Pvt.LTD.

Participating in training program on “GOOD LABORATORY PRACTICE” organized on 30th December 2014 at Panexcell clinical Lab Pvt.LTD,Mumbai.

Attended & participated as a delegate during Tata Memorial Centre Platinum Jubilee Conference “HEALTHCARE: A Commodity or Basic Human Need?” held at Tata Institute Of Fundamental Research Mumbai from 27th to 29th January 2017.

Good Clinical Practice Course (Basic And Advance Course) CRS And DAE-CTC 17 Th November, 2018

As a observer for SIDCER-FERCAP Survey which was held in ACTREC, 2019

12th ANNUAL SHORT COURSE IN CLINICAL RESEARCH METHODOLOGY -27th and 28th July, 2019 CRS AND DAE-CTC

Participated in The First National "Administrative Excellence Symposium 2020" conducted in TMC-ACTREC.

Online certificate course in “Current regulatory requirements for conducting clinical trials in India for investigational new drug/new drug (Version 2.0)”organized by CDSA

Online certificate course in “Regulatory requirements for medical devices including in vitro diagnostics in India (Version 2.0)”organized by CDSA

"Virtual Workshop- 13th Annual Short Course in Clinical Research Methodology" held on 5,12,19,26 September 2020

Completed online certificate course “ Understanding Clinical Research: Behind statistics”

Completed Online Certificate course on Pharmacovigilance organized by Omasy Research Institute

Completed Clinevo eTMF System Training certificate course on 30th July, 2021

Completed Clinevo rSDV System Training certificate course on 30th, July, 2021

PERSONAL DETAILS:

Date of birth : 8/11/1981

Sex : Female.

Marital Status : Married

Nationality : Indian

Language : English, Hindi & Marathi

Know

Permanent Address : Om MangalmurtyCHSPlot No-50, Flat No-203,

Secrot-44, NerulSeawoods, Navi-Mumbai 400706.

DECLARATION :

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

PLACE: NAVI MUMBAI

DATE : (GAURI ROHAN SHETKE)

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