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[QUOTE=Guest-IJT;152212][b]Name [/b]: Venkatesh M Kongari
[b]Email [/b]: venkatesh_kongari AT yahoo.com
[b]Designation / Skillset[/b] : Clinical research associate
Myself, Kongari Venkatesh Maleshkumar having an experience of 01year as a CRA at Lambda therapeutic research Ltd. I have done M.Pharma in Clinical Pharmacy from ROFEL Shri G.M. Bilakhia College of Pharmacy, Vapi (Gujarat) with specialization in Pharmacotherapeutics, Clinical Trials & New Drug Approval.
I am looking forward for the job opportunity in clinical trials as CRA. I have successfully accomplished training for ICH/GCP. 
I would be glad to have an opportunity to prove my knowledge and skills in your organization.

[u][b]Resume[/b][/u] :
 
CAREER OBJECTIVE
To work in professional environment, which influences my education and expertise, contribute effectively in a dynamic and continuous learning environment, and develop organizational insights, proficiency and innovativeness essential in the today’s scenario.________________________________________
PROFESSIONAL EXPERIENCE
LAMBDA THERAPEUTIC RESEARCH LTD., AHMEDABAD.
CLINICAL RESEARCH ASSOCIATE – CLINICAL PHARMACOLOGY AND MEDICAL AFFAIRS DEPARTMENT (WORKING SINCE APRIL 2010 - PRESENT)
________________________________________
[b]Area of expertise as a Clinical Research Associate [/b]:
During my 01 year of tenure in a field of clinical research organization I had an experience of handling various BA/BE studies, multiple dosing trials, and some special studies like Phase-I trials and also working on e-CRF.
________________________________________
[b]JOB RESPONSIBILITIES [/b]:
- ENSURE MONITORING, PROJECT COORDINATION, AND CONDUCT AS PER PROTOCOL AND SOPS.
- WORK IN CLOSE COORDINATION WITH THE PRINCIPAL INVESTIGATOR, SPONSOR AND IEC.
- MAINTAINS TIMELY AND EFFECTIVE COMMUNICATION AMONG TEAM MEMBERS AND SITE STAFF.
- MAINTAINS CURRENT REGULATORY DOCUMENTATION ACCORDING TO ESSENTIAL REGULATORY DOCUMENT GUIDELINES (ERDG) AND TRIAL MASTER FILE (TMF) PLAN.
PARTICIPATES IN TMF AND ON-SITE AUDITS AS REQUESTED.
- PATIENT COUNSELING AND ALL STUDY DOCUMENTATION IS RECORDED, HANDLED AND STORED TO ALLOW ACCURATE REPORTING, INTERPRETATION AND VERIFICATION.
- OBTAINS INFORMED CONSENT UNDER MINIMAL SUPERVISION OF THE INVESTIGATOR(S) AND EDUCATES PARTICIPANTS REGARDING STUDY REQUIREMENTS.
- MONITOR PROJECT ACTIVITY, SCHEDULE TRAINING VISITS, AND MAINTAIN TRAINING RECORD AND PREPARES FOR MONITORING VISITS.
- RETAINS ALL STUDY RECORDS IN ACCORDANCE WITH SPONSOR REQUIREMENTS..
- PREPARE SERIOUS ADVERSE EVENT (SAE) REPORTS AND REPORTS TO SPONSOR/CRA AND ETHIC COMMITTEE AS PER THE GUIDELINES.
[b]- ASSUMES RESPONSIBILITY FOR SITE MANAGEMENT AND SITE STAFF PERFORMANCE INCLUDING [/b]: MONITORS ALL TYPES OF CLINICAL TRIALS & PARTICIPATES IN SITE VISITS.
- ASSURES PRINCIPAL INVESTIGATOR (PI) INTEGRITY AND ALSO COMPLIANCE WITH ALL PROTOCOL REQUIREMENTS.
- ASSURES EFFECTIVE PATIENT IDENTIFICATION AND RECRUITMENT PLAN IS IN PLACE.
- ASSURES TIMELY REPORTING OF AES/ SAES AND PROTOCOL VIOLATIONS.
- REGULARLY PERFORMS INVESTIGATIONAL PRODUCT (IP) ACCOUNTABILITY & REGULARLY REVIEWS THE STATUS OF CONTENTS OF THE SITE REGULATORY BINDER.
- ASSURING SOURCE DOCUMENT VERIFICATION (SDV) WITH TIMELY COMPLETION AND SUBMISSION OF CRFS ACCORDING TO CLINICAL MONITORING PLAN (CMP) AND / OR DATA MANAGEMENT PLAN (DMP).
- ASSURES TIMELY AND ACCURATE COMPLETION OF DATA CLARIFICATION FORMS (DCFS).
- MAINTAINS AWARENESS OF KEY STUDY PERFORMANCE INDICATORS FOR OWN SITES, E.G. TCRS, PATIENT ENROLLMENT, SAES.
- ATTENDS CLINICAL MONITORING STAFF MEETINGS, PROJECT TEAM MEETINGS, CLINICAL COMMITTEES, AND CLINICAL TRAINING SESSIONS ACCORDING TO THE PROJECT COMMUNICATION, MONITORING AND / OR TRAINING PLANS.
- ENSURE PROPER INITIATION AND CONDUCT OF THE TRIAL.
- ENSURE PROPER DOCUMENTATION OF ADVERSE DRUG REACTIONS, NOTE TO FILES, DEVIATIONS ETC., AND REPORTING OF SAES AS PER REGULATORY REQUIREMENTS.
- CHECK ALL THE FORMS AND GENERATE PROTOCOL DEVIATIONS.
- SEND CLINICAL UPDATES TO ALL CONCERNED AND ECRF ENTRY FOR GLOBAL SPONSOR.
- PATIENT COUNSELING AND ALL STUDY DOCUMENTATION IS RECORDED, HANDLED AND STORED TO ALLOW ACCURATE REPORTING, INTERPRETATION AND VERIFICATION.
- OBTAINS INFORMED CONSENT UNDER MINIMAL SUPERVISION OF THE INVESTIGATOR(S) AND EDUCATES PARTICIPANTS REGARDING STUDY REQUIREMENTS.
- MONITOR PROJECT ACTIVITY, SCHEDULE TRAINING VISITS, AND MAINTAIN TRAINING RECORD AND PREPARES FOR MONITORING VISITS.
- RETAINS ALL STUDY RECORDS IN ACCORDANCE WITH SPONSOR REQUIREMENTS..
________________________________________
[b]M. Pharm Project Details [/b]: 
[b]Title [/b]: “To study the safety and efficacy of adding Sitagliptin or Vildagliptin in Type-2 Diabetic Patients Receiving Metformin, Pioglitazone and a Sulfonylurea Combination, Showing Inadequate Glycemic Control:
A Phase-IV Open Label Study”
[b]Project guide [/b]: Mr. Mittal dalal.
 
________________________________________
EDUCATIONAL QUALIFICATIONS 
Examination University/Board Year of passing Percentage obtained
M.Pharm
(CLINICAL PHARMACY)
 V.N.S.G.U 2009 61 %.
B.Pharm R.G.U.H.S.,
BANGLAORE 2006 60%
VNSGU - Veer Narmad South Gujarat University
 RGUHS - Rajiv Gandhi University of health sciences
________________________________________
PROFESSIONAL EXPERIENCE
- Worked as “6 Months Experience in Bharat Serums and Vaccines ltd as a Medical Representative.
- Attended the workshop on ICH GCP conducted by Lambda Therapeutic Research Ltd in DECEMBER, 2010.
- Appeared Online ICH-GCP training on 29/11/2009 from pharmaxm.com
- Appeared Online ICH-GCP training on 09/12/2009 from [url]www.onlinegcp.com[/url]
________________________________________EXTRA ACTIVITIES
- ANCHROM Enterprises (I) P. Ltd. Mumbai for TLC/HPTLC Training on 8th Mar.,2008.
- Preconference Workshop on Toxicology Studies and Data Management and 26th Annual Conference of Indian Pharmacology Society Gujarat Chapter, VAPICON, organized by ROFEL Shri G.M. Bilakhia College of Pharmacy, Vapi on March 15-16th, 2008
- AICTE sponsored International Conference on Translational Pharmacology & 41st Annual Conference on Indian Pharmacology Society organized by Dept of Pharmacology, AIIMS, New Delhi on December 18-20th, 2008.
- CME on “ Rational Use of Blood and Blood Components” organized by Nukem Blood Bank & Rotary Suzlon Blood Component Center Haria L.G. Rotary Hospital, Vapi on February 3rd, 2008
 
________________________________________COMPUTER PROFICIENCY
- Microsoft Office, MS DOS, Internet, Windows XP ________________________________________
________________________________________ REFERENCE
- Dr D D. Santani (Ph.d)
 Professor and director, PG and Research,
 Rofel, Shri G. M. Bilakhia college of Pharmacy, Vapi-396191, Gujarat.
- Mr. Mittal dalal,
Assistant Professor,
 Rofel, Shri G. M. Bilakhia college of Pharmacy, Vapi-396191, Gujarat.
- Dr. Alpeshkumar Patel,
Senior Manager, Principal investigator.
Lambda Therapeutic research, Ahmedabad.
________________________________________I hereby declare that the above mentioned information is authentic and true to the best of my knowledge.
[b]Date [/b]: Your’s Sincerely,
 Venkatesh M. Kongari.
-------------------------------------------------------
[b]More Information about this submission and submitter [/b]:-
___________________________________________________
[b]Submission ID  [/b]: 4239618
[b]Date & Time  [/b]: 11th Jun 2011 6:34 AM (UTC)
[b]IP Address  [/b]: 124.124.243.130
[b]Browser Info  [/b]: Mozilla/4.0 (compatible; MSIE 8.0; Windows NT 5.1; Trident/4.0; .NET CLR 1.1.4322; .NET CLR 2.0.50727; .NET CLR 3.0.4506.2152; .NET CLR 3.5.30729; .NET4.0C; .NET4.0E; InfoPath.2)
[b]Predicted Country  [/b]: India[/QUOTE]

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