I wish to pursue a challenging career in Clinical Research Operations with enormous capabilities to contribute my knowledge and skills in a position with fast steady growing and dynamic firm.Personal strengths :
** Aptitude to learn new ideas and quicker adaptation to the environment,
** Consistent academic Profile, Hard working,
** Good knowledge in ICH GCP, USFDA, EU, ANVISA, MOH, Schedule Y etc.,
** Effective team member and motivating team.Education :
** Qualified in GATE**2008 with 98.24 percentile. (ALL INDIA RANK**475)
** Got state 68th rank in ECET**2004.M.Pharmacy : (Pharmacoloy) ANDHRA UNIVERSITY, Visakhapatnam 2010 9.1/10
DistinctionB. Pharmacy : GIET School of Pharmacy, Rajahmundry, E.G. Dt., A.P. 2008 73.2
DistinctionD. Pharmacy : S.V. Polytechnic, Tirupathi. 2004 74.4
DistinctionIntermediate : Board of Intermediate Education 2002 86.6
DistinctionS.S.C. : Board of Secondary Education 2000 66.00
I classProfessional Experience :
** Working as a Clinical Research Associate, From Nov 2010 to till date at GVK BIO SCIENCES Pvt., Ltd., Clinical Pharmacological unit, Hyderabad, India.JOB PROFILE :As a CRA :
** Study in charge, which includes Planning and presentation of clinical research study information, supervision of study related activities and Clinical data review.
** Execute the studies as per protocol, SOP’s, GCP and other Regulatory requirements.
** Checking the correctness, completeness, authenticity and designing of the CRF’s.
** Communication of Study Updates with Investigators, Sponsor and Project management.
** Reporting of the adverse events and Serious Adverse Event to the Sponsor and IEC.
** Preparation of all pre**study, during study & post –study documents related to study.
** Co ordination with all concerned departments for proper planning &execution of studies.
** Co ordination and being responsible for the designing and preparation of Clinical Study reports, and summary reports as per regulatory requirements.
** Review of protocol, ICF, protocol training sheet, reports, study completion summary for submission to IEC, docket.
** Good Knowledge in reporting of study to the sponsor.
** Preparation and review of SOP’s according to the Regulatory requirements.
** Working knowledge of ICH**GCP's guidelines and FDA regulations.
** Good communication and presentation skillsAs Q.A Personnel :
** Carry out In process and retrospective audits of various phases of BA/BE studies as per SOPs ,protocol & report to manager **QA
** Review of clinical, general & QA SOPs, calibratio Sponsored links :
n documents, raw data &study reports.
** System audit of in**house /contracted facilities.
** Checking of study requirements before starting the study.
** Review of ICFs, Screening Records and Protocol before submission to IEC & review of IEC approval process.
** Verification of study file, essential documents, clinical updates, raw data and study report for data accuracy.
** Responsible for verification of study related documents for archival.
** System audit of in**house/contracted facilities.
** In**process audit of Check**in, Dispensing and Dosing.
** Retrospective audit of ICFs, Screening Records, Raw data and Reports.
** MedDRA review.As a Site Monitor :
** Perform Site Identification and conduct Feasibility Studies
** Perform Site Selection Visit, Site Initiation Visits in accordance with the protocol and other applicable regulatory guidelines including local regulatory guidelines.
** Send Follow Up letters to sites and submit Visit Reports to the Clinical Team Leader/Project Manager as required.
** Keep a close association with site s for : Patient Recruitment, Patient Follow Up, Protocol related activities
** Act as a communication Link between Sponsor and the site
** CRF retrieval as per the project instructions
** Coordinate and distribute Clinical Study Material to study sites
** Archival of study documents.Audits faced :
** Faced WHO, ANVISA and FDA audits carried out at GVK Bio Sciences in year 2010 and 2011 respectively.Trainings Underwent :
** Underwent In**house training on ICH**GCP Conducted in GVK Bio Sciences, Hyderabad.Certification Courses :
** Completed Certification courses in Clinical Trials and Clinical Data Management from CLINI MINDS, Hyd.
** Completed Post Graduate Diploma in Computer Applications (PGDCA).
** Well known about MS** Office, Excel and Internet.Areas of Interest :
** Clinical Data Management
** Clinical TrialsProject Work On Clinical –Studies :Title : EVALUATION OF PSYCHO**EMOTIONAL STATUS IN HUMANS BASED ON THE SALIVARY PROTEIN PROFILETeam size : 1Duration : 1 Year 2 Months (Aug 2009**Oct 2010)Description : In the present work, it was analyzed over 100 samples of saliva collected from 100 donors, among which 20 people with normal activity of consciousness, 20 depression patients,20 schizophrenia patients, 20 people with increased positive activity of consciousness and 20 people with spiritual qualities The basic method of protein estimation in saliva is SDS**PAGE (Sodium Dodecyl Sulphate**Poly Acrylamide Gel Electrophoresis).
Present study was approved by INSTITUTIONAL ETHICS COMMITTEE (IEC), Andhra University, Visakhapatnam.
Obtained data suggested that human psycho**emotional state has influence on protein composition of human saliva.
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