Project Manager High School
Resume:
CRA-RESUME
KAUSHAL SHINDE
Permanent address:
**, ********* ***** ******** *******,
Post- usarli khurd,
ONGC, New Panvel,
New Mumbai.
E-mail: **************@*****.***
*******.*********@*****.***
Contact No: +91-943*******
( Willing to relocate)
Career Objective
I am also looking forward to opportunities of growth both on intellectual and professional level.
To be associated with Progressive Organization that gives scope to apply my knowledge and skills in areas of Development and Application to take part in the team that dynamically works towards the Growth of the Organization.
Projects
1) I have done 4 site selection for oncology protocols till yet, and while I have 3 years exp. For managing clinical trial sites .
1)Gastronox study for ph-III open level, multi-centric, for inoperable gastro-esophageal cancer.
Status: completed.
Duration: 3 years and follow up going on.
Study: Comparable study.
2)LEP-ETU, breast cancer study for ph-II
Status: completed.
Duration: 1 year and follow up going on.
Study: open-level
3)Locally advanced Squamous cell-carcinoma for head and neck, ph-IV study for Post Marketing Survey .
Status: enrollment.
Duration: 3years.
Study: Pilot study.
4) Study of taxotere in indian patients. ph-iv study for post marketing survey.
Status: enrollment.
Duration: 2years.
Study: Pilot Study.
Experience
Worked as CLINICAL RESEARCH ASSOCIATE in Oncology Projects at Bengal Oncology Research, Kolkata, West Bengal. From july 2008 to present.
Worked as CLINICAL RESEARCH ASSISTANT in PH-III study for malaria. Under Dr.K . kulkarni. MD,Medicine. At mangeshkar hospital pune, From jul 2007 to jun 2008.
Responsibilities:
1) Regional/local sites regular monitoring and coordination with site CRC.
2) Conducting (CRA) Site Visit, Investigator team interaction/meeting in the site.
3) Clinical trial document maintenance (Source data verification, ICD review, SAE reporting, Drug accountability).
5) Ensure the maintenance of Investigator site file. (ISF)
6) Ensure Coordination with central lab and source document amendments.
7) Mentoring site CRC in trial monitoring visits.
9) Site interaction with staff during site visit.
10) Ensure Adverse event reporting with SAE.
11) Ensure Compensation agreement maintenance with time line management for recruitment of subjects.
12) Report to Principal Investigator and Project Manager.
13) Ensure delivery of study drug consignment records maintenance.
14) Coaching trial protocol at site initiation.
15) Coordinating with the ethics committee, which safeguards the rights, safety and wellbeing of all trial subjects
16) Managing regulatory authority applications and approvals that oversee the research and marketing of new and existing drugs;
17) Liaising with doctors/consultants (or investigators) on conducting the trial;
18) Training site staff to industry standards
19) Ensuring that data tracking on to the CRFs is consistent with patient clinical notes, known as source data/document verification (SDV)
20) Discussing results with a medical statistician, who usually writes technical trial reports
21) Archiving study documentation and correspondence;
22) Preparing Final clarification with site personnel after tracking the DCF (data clarification forms and MCF (monitor clarification forms at trail site visits.
Total Exp: 4years, Present CTC- 3.0 lakhs per annum.
Proficiency
Type Knowledge
Clinical Research ICH Guidelines, Regulatory Affairs, Pharmacovigilance, Site Management, Data Management, Biostatistics
Professional Skills
*** Post Graduate Certificate course in Clinical Research(ICH-GCP Guidelines) with Clinical data management from, Bio Informatics centre, University of pune.
Academic Details
Qualification Year of Passing Board/University Institute
PG Course in Clinical Research & Clinical Data Management August 2007 University of Pune, India Bioinformatics Center, Pune University
M.Sc. (plant biotech) July 2004 Pt. Ravi shankar shukla University,Raipur- (C.G.), India Govt. College of science, Raipur-(C.G.), India
B.Sc. (Industrial Microbiology)
June 2002 Pt. Ravi shankar shukla University,Raipur- (C.G.), India Govt. College of science, Raipur-(C.G.), India
H.S.S.C. April 1999 M.P.BOARD, India National Convent High school, Raipur.(C.G.).
India
S.S.C. Mar1996 BIHAR BOARD, India Shivaji High school, Dhanbad
India
References
Dr. Alit Bhatt (*********@**********.***)
Medical Officer - Global Medical Affairs,
Kendle Data and Technologies (India) Private Limited ,
Ahmedabad Area,
India
Dr.Somnath Sorcer, (*************@*****.**.**)
Project Director/ Investigator,
Bengal Oncology Centre,
Kalighat, Kolkata,
India
Dr. P.Subbaryan. (***********@*****.***)
Head of Audit Operations.
Neeman Asia Medical International,
Worli, Mumbai-400018
Ph: +919*********
Dr. Ramananda Nadig (*****.***@*****.***)
Chief Operating Officer,
Manipal Acunova Pvt. Limited,
Bangalore-Karnataka.
Dr. S.M. HASSAN.(******@**************.***)
Senior Medical officer/ adviser (Pharmacovigilance)
Institute of one world health,
Boring Canal Road,
Patna
Mobile: +919*********
Personal Details
Name kaushal Shinde
Date of Birth 20th December, 1981
Father’s Name Mr. S.K.Shinde
Languages Marathi ,English , Hindi
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