Clinical Research
Resume:
VIGNA PRASAD.J
Email: ***********.*@*****.***
Mobile No. :
Address:
No.364, Indra Nagar, Melmonavoor,
Vellore. Pincode-632 010.
OBJECTIVES
Pursuing an experience where I will be able to utilize my life experiences as well as my
interpersonal skills, to not only allow myself to grow personally and professionally, but to firmly
contribute towards the achievement of the mission and values of (VIGNAPRASAD.J)
QUALIFICATION
“M.Sc., in Clinical research & Regulatory Affairs” in “Madras Medical Mission”
Affiliated to Sikkim Manipal University.( 2010 – 2012)
B.Sc., in Microbiology in Mazharul Uloom College, Ambur, Vellore.
(2005-2008)
PGDCA, Arul Institute, Vellore. (2007-2008)
ACADEMIC PROJECTS
M. Sc.,- “A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Assess
the Efficacy and Safety of Drug A Treatment on Mortality and Morbidity in Heart
Failure (HF) Subjects with Symptomatic Left Ventricular Systolic Dysfunction and
Anemia and its submission to DCGI as per regulations of SCHEDULE Y.”
M.Sc., - “A Report on the Hands-on training obtained for a period of Six Months at the
Department of Clinical Research, Madras Medical Mission, Chennai”
TRAINING & CERTIFICATES
Site SOP training at Madras Medical Mission
GCP training session attended in Madras Medical Mission conducted by Lotus Clinical
Research Academy Pvt. Ltd. (08-Mar-2013)
Participate on Workshop of Diabetes Education By R. M. Diabetes Education &
Foundation.
M.S. Word, Excel, PowerPoint & Internet.
PERSONAL SKILLS
Positive Attitude, Determined and High Energies.
Hard Working, and Sincere.
Good decision making and analytical skills.
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PROFESSIONAL EXPERIENCE
Internee from August 2011 – July 2012 in the Department of Clinical Research, Madras
Medical Mission, Institute of Cardiovascular Diseases, Chennai.
CURRENT WORKING EXPERIENCE
From Aug 2012 to till date working as Jr. Clinical Research Associate in Department of Clinical
Research, Madras Medical Mission Hospital, Chennai for the following Multi center drug trails .
Indication Clinical Phase Role in Trial Duration
Research Coordinator April 2012-2014
STEMI Observational
Research Coordinator July 2012-2014
Dyslipidemia Observational
Sep 2012 – Ongoing
Research Coordinator
CAD Device Phase IV
Feb 2013 – Ongoing
Research Coordinator
CAD Device Phase IV
Contrast
Induced
Apr 2013 – Ongoing
Research Coordinator
Observational
Nephropathy
(Drug Trial)
Jr.CRA Sep 2012 - Ongoing
TN STEMI Observational
WORK RESPONSIBILITY
Completing feasibility questionnaire for upcoming studies
Inventory planning and management of lab kits, copies of ICD and other study
documents.
Performed drug accountability and maintained logs of medication and non-medication
supplies at site.
Associated with the regulatory groups and prepared all relevant documentations to obtain
approval of Ethics Committee.
Handled approval process for Clinical Trial Agreements as per SOP of Institution.
Study Budget handling
Maintaining Source data.
Maintenance and Periodic review of Investigator site file.
CRF or eCRF Entry.
Query Resolution in Data clarification form (DCF) and clarify open queries (eCRF)
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Preparation of SAE reports to Investigator or site members and Sponsor and EC and
DCGI and Licensing Authority within timeline.
A compensation activity for the SAE’s as per new Gazette within timeline.
Assisted Principle Investigator, Co- Investigators, Sub-Investigators in all study related
internal and external requirements for pre-study procedure also
Prepared and maintained study master file of various clinical studies
Performing inventory for Investigational Product (IP) and dose administration procedure
to the subjects and drug compliance. Assisted Monitors / Auditors during the conduct of
clinical study
Entry of data in Electronic Case Record Form in software of PHEEDIT
Site Monitoring as a CRA and retrieval of CRF
Coordinating Sites activities.
ETHICS COMMITTEE RELATED:
Notification of Serious Adverse Events and AE to Sponsor/CRO and EC within timeline.
Preparing Ethics Committee submission Letter and Annual Reports to Ethics Committee.
PERSONAL PROFILE
Name : VIGNA PRASAD.J
Father’s Name : A. Jagadeesan
Date of Birth : 04-07-1986
Gender : Male
Marital Status : Single
Nationality : Indian
Languages Known : Tamil and English
DECLARATION
I hereby declare that the above information furnished is true to the best of my knowledge and
belief.
Place : Chennai
SIGNATURE
Date : 24/04/2015
(VIGNA PRASAD. J)
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