S/o G.veera Bhadra rao,door no 7-114,Mondivari street,
Payakaraopeta-531126, vizag district ph no : +91 8904336769.E-mail : rajeshgollapudi25 AT gmail.comCareer Objective :
Seeking for the position of Clinical Research Associate in the medical field while merging into a globally focused organization that will purposefully utilize my qualifications while offering several opportunities to integrate personal enrichment with professional goals.Professional Experience :
Total 2.10 yearsclinical Experience as Research Associate from Sponsor side and CRO in Bioavailability and Bio-equivalence studies
Research Associate in Clinical Research and Development Division of Hetero Drugs Ltd., Hyderabad, India.Projects Details :
10 BA/BE projects and Three phase-III clinical trials were monitored.Role : Clinical Research Associate(Monitor)
Research Associate in Clinical Research Division of Manipal Groups Ltd(Ecron AcuNova) as“Manipal Acunova Ltd” Mangalore,IndiaProjects Details :
50 BA/BE projects(US FDA,EMEA& canadian regulatory) involved as a Research Associate
14BA/BE projects(USFDA) Handled as a Sub investigatorHandled Molecules :
1.CARBIDOPA AND LEVODOPA
6.SILDENAFIL CITRATE7. ASPIRIN/EXTENDED-RELEASE DIPYRIDAMOLE :
04 BA/BE projects Handled as a QC AssociateRole : Clinical Research Associate:Responsibilities :
Coordinating and being responsible for the selection of investigators, study initiation, training, monitoring and collection of data is on track.
Literature collection for investigational products.
Preparation of study documentation materials such as CRF, Protocols, Clinical Reports & study realted documents for BA\\\\\\\\BE Studies
Monitoring of the clinical study according to SOP’s, ICH/GCP and applicable regulatory guidelines.
Verification of source data, protocol review, & approval.
Preparation of raw Data for clinical summary reports
Reviewing of ICF’s,Protocols,study summary reports & CSR ‘s.
Dosseier Submission to EC and DCGI
Study and screening Icf’s presentations.
Particpitaion of study realted activities.
Prepartion of standard operating procedures.
Volunteers Safety Follow Up
Reviewing Study files
Pharamacy realted work
Maintaining calibartions of instruments.Career highlights :
Successfully submitted conducted studies to USFDA regulartories
Two USFDA and WHO ,DCGI audits faced successfully with out any observations .Summary :
knowledge of monitoring procedures.
Detailed knowledge of GCP and ICH guidelines including basic understanding or regulatory requirements.
Comprehensive knowledge of S.O.P. Sponsored links :
s for site monitoring.
Basic knowledge of clinical trial process
Management of Serious adverse event submission to Local regulartory bodiesProfessional Experince :
As a part of B. pharm degree undergone 30 days Industrial Training at M/s. formulations manufacturing unit of Lord venky Pharma Ltd.,Yanam.
Educational Qualifications :
Bachleor of Pharmacy from Pallavan pharmacy college,Dr.MGR university, Tamilnadu in 2009.
Diploma in Pharmacy from Shoba college of pharmacy Erode in2005
Intermediate from board of intermediate education A.P. March 2003
S.S.C. from State board of secondary education, March 2001.Paper presentation Attended :
Attended the Paper Presentation On Inhaled Insulin at Anna University Trichy Tamilnadu 2009.Training courses :
Workshop on “Statistical Analysis Using R”; (MAY 2012) Kasturba Medical College, Manipal, IndiaCertification :
GCP test passed with 77% conducted by Ecronacunova Ltd Bangalore karanataka 2011.Technical Exposure :Operating System : Windows 98/2000/XPGraphics Softwares : Excel and Power point.
Statistical Analysis Using RAreas of Strength :
Comprehensive clinical research knowledge,
Problem solving/ Decision making,
Ability to deal with people in team or individually
Easily adoptable to any work environment.
Passion to learn and share knowledge
Hard working and flexible in learning new thingsPersonal Profile :Name : Gollapudi RajeshDate of Birth : 10-08-1986Marital Status : MarriedLanguages Known : English,Telugu, Tamil& kannadaPresent Address : C/o.Hornould D souza
Morning star Buiding
Mangalore -575001Permanent Address : S/O. G.veera Bhadra rao.
Vizag (Dt). A.P.
Ph :-+91 9247860941Present CTC : 2.5 lakh per annumExpected CTC : 3.5 lakh to 5.0 lakhNotice period :45 days
References can be provide as per requirementDECLARATION :
I hereby declare that the details furnished above are factually correct to the best of my knowledge .Place :Date :
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