Clinical Research Associate Resumes in India-Andra Pradesh-Hyderabad: nafeesa

Clinical Research Associate Resume

Contact Candidate

Name:

nafeesa

Location:

India-Andra Pradesh-Hyderabad

Experience:

Willing to Relocate:

Willing to Travel:

Most Recent Job Title:

Clinical Research Associate

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Objective:

I wish to apply for the post of clinical Research Associate.

Resume Text:

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men, Osmania University, Hyderabad. 1988 First Botany, Zoology, Chemistry
Intermediate Stanley Girls Junior College, Hyderabad 1984 First Botany, Zoology, Physics, Chemistry
Secondary School Certificate Rosary Convent High School, Hyderabad 1982 First Gen. Science, Maths, Social, Studies

Title of Ph.D Thesis : ``The Incidence of Hepatitis C Virus infection in Alcoholics, Post transfusion and Renal Transplant subjects’’

Work Experience:

Year 1994 – 2000 : Worked as a Research Asst. in a project based on Molecular and Immuno Characterization of Hepatitis Viruses (hepatitis A, hepatitis B, hepatitis C and hepatitis E viruses) in Indian patients at Centre for liver Diseases, Deccan College of Medical Science & Allied Hospitals, Hyderabad in collaboration with Colorado Univ. of Health Sciences, Denver, USA.

Year 2000 – 2004 : Worked as a Research Scientist in a project based on Prevalence and Genotype distribution of Hepatitis B and C virus infection in Indian patients at Centre for liver Research and Diagnostics, Deccan College of Medical Sciences &Allied Hospitals, Hyderabad.
Year 2004 – 2005 :Worked as a Lab Specialist in Ministry of Health, Saudi Arabia.
Year 2005 –till date : Working as a Clinical Research Associate at Centre for liver Research and Diagnostics, Deccan College of Medical Science & Allied Hospitals, Hyderabad.
I have acquired experience in various therapeutic areas in virology. I also have extensive knowledge in many areas of governing clinical trials, including clinical monitoring, project and resource management, GCP training and auditing of clinical trials. As a project leader and clinical research manager, I have managed and monitored clinical trials (Phases 2,3 and post marketing studies ) including sponsor driven studies and trials done in collaboration with large corporate groups.
I have completed nearly 8 clinical trials conducted by various national and multinational organizations.
My present job involves adhering to the protocol and monitor that the team follows the protocol, maintaining the CRFs for the trials, reports and also coordination with the institute conducting the trial. I am also actively involved in answering the medical queries and counseling the patients. Also have experience in regulatory documentation and submission as the incharge of organizing and documentation for the Institute of Ethical committee at Owaisi Hospital and Research Centre.
I have also been extensively involved in clinical trial projects as Clinical Trial Associate from 5th June 07’ to 5th Oct 07’ in Biomed Informatics (Drug Discovery & Clinical Research Centre), Medwin Hospital, Hyderabad. The project comprises of statistical application in SAS environment to find out the efficacy and safetyness of the drug. Responsibilities include study of the data by producing Tables, Listings, and Forms as per 21 CFR US FDA guidelines. Main thrust areas include presentation of demographic data, Adverse event / Serious adverse event analysis reports, Comparison of efficacy of the investigational product with respect to market available drug in intermittent analysis
.
Training and workshops attended:
Have been trained in Clinical trials at Centre for Liver Research and Diagnostics, Deccan College of Medical Sciences & allied Hospitals, Hyderabad which includes study of Protocol, Informed Consent Process, CRF filling, Drug accountability and Safety.
Attended the Certificate Course in Clinical trials training conducted by Biomed Informatics, Medwin Hospital, Hyderabad from 25th April to 25th May 2007 and specialized in ICH/GCP guidelines, Biostatistics & SAS Clinical.

Drug Trials Involved:
1. Efficacy and safety of PEG-Inferon (Peg Interferon alpha 2b) for the treatment of
Chronic Hepatitis B - An Open Labelled Multi-centric study (Virchow BiotechPvt.
Ltd., Hyderabad).
2. Phase III study to evaluate immunogenecity and reactogenecity of a recombinant
hepatitis B vaccine in healthy subjects. (Serum Institute- Pune, Bharat Biotech-
Hyderabad).
3. Therapy in patients with chronic hepatitis C: A randomized control study of
interferon and combination of interferon with glycyrrhizin (ICMR, New Delhi).
4. Efficacy of pegylated interferon alpha-2b in combination with Ribavirin in chronic
HCV infection.
5. Multicentric Open Randomized controlled clinical trial of Combination therapy
with Ribavirin and oral Glycyrrizin in decompensated HCV-induced cirrhosis
(ICMR, New Delhi).
6. A Multicentric randomized controlled clinical trial of adefovir and glycerrhizin
versus adefovir and placebo in HBV related cirrhosis (ICMR, New Delhi).
7. Efficacy and safety of Inferon (Human Interferon alpha 2b) for the treatment of
Hepatitis B - An open labeled Multicentric study in India. (Vircow Biotech Private
Limited, Jeedimetla, Hyderabad).
8. Double-blinded, repeated dose concept validation study for the evaluation of
safety and tolerability and the effect of a daily dose of 900mg and 1800mg CMI
III, an optimized and standard extract preparation of Phyllanthus amarus,
on clinical parameters of chronic hepatitis B in 30 patients with untreated chronic
hepatitis determined by HBV DNA load and plasma HBsAg (Phyrix Germany).

Laboratory Techniques Known :

Molecular Biology :
- Isolation of DNA and RNA from serum, whole blood and tissue specimens.
- Polymerase Chain Reaction assay for the amplification of DNA and RNA using
specific primers.
- Restricion Fragment Length Polymorphism (RFLP) analysis of DNA using
restriction enzymes.
- Agarose Gel electrophoresis
- PAGE Gel electrophoresis
- Isolation of IgG and IgM from serum sample by column chromatography.
- Southern blot hybridization.
- Western blot
- Purification of PCR products by spun column chromatography.

Virology:
- Diagnosis of Hepatitis Viruses i.e Hepatitis A, Hepatitis B, Hepatitis C and
Hepatitis E Viruses by Enzyme Linked Immuno Sorbent Assay (ELISA).
- Detection of Hepatitis B Virus DNA by Polymerase Chain Reaction assay.
- Detection of Hepatitis C Virus RNA by Reverse transcription – Polymerase
Chain Reaction assay.
- Quantification of Hepatitis B virus DNA and Hepatitis C virus RNA using Real
time PCR and Cobas Amplicor Analyser.
- Genotyping of Hepatitis C Virus by RT-PCR method using type specific
primers and by RFLP method.
- Genotyping of Hepatitis B Virus by RFLP method.

Microbiology- Bacteriology
- Gram staining of various specimens and fluids like blood, sputum, CSF, pus
etc, for the identification of different kinds of bacteria.
- Growth of fastidious bacteria in blood using automated Bactec instrument.
- Isolation of bacterial organisms from blood, urine, sputum, CSF, pus, etc, by
pure culture technique like serial dilution, streak plate method and
enrichment culture on different types of culture media like blood agar,
chocolate agar, Mac
Conkey agar etc.
- Direct Smear for fungus- KOH preparation.

Routine Clinical Biochemistry:
- Liver Function Tests
- Kidney Function Tests
- Cardiac Profile Tests
- Diabetic Profile Tests

RESEARCH PAPERS PUBLISHED:

1. Title: High prevalence of Hepatitis C virus infection and genotype
distribution among general population, blood donors and risk groups.
Authors: Khaja MN, Madhavi C, Nafeesa Farees, Habibullah CM et al.
Journal : Infection, Genetics and Evolution; 2005 June 27

2. Title: Prevalence, risk factors and genotype distribution of HCV and HBV
infection in the tribal population : a community based study in south
India.
Authors: Chandra M, Khaja MN, Nafeesa Farees, Habibullah CM et al.
Journal : Tropical Gastroenterology 2003 Oct – Dec ; 24 (4) : 193 - 195

3. Title: Prevalence of Hepatitis B and Hepatitis C viral Infections in Indian
patients with Chronic Renal Failure
Authors: Madhavi C, Khaja MN, Nafeesa Farees, Habibullah CM et al.
Journal : Intervirology 2004 ; 47: 374-376

RESEARCH PAPERS PRESENTED IN THE CONFERENCES:

• ‘Prevalence of HCV Infection in post transfusion associated hepatitis’ X Annual convention of Indian Virological Society and National Symposium of Viral Diseases of Socio – economic importance relevant to India, held in Trivandrum, India from 16 – 18 January 1995.

• ‘Prevalence of HCV infection in Blood Donors’, XXXVI Annual Conference of Indian Society of Gastroenterology held in Cuttack, India from 2 – 5 November, 1995.

• ‘Chronic Hepatitis C infection and its relation to Reactive Oxygen Species’, XXXVIII Annual conference of Indian Society of Gastroenterology held in Hyderabad, A.P., India from 6 – 9 November, 1997.

• ‘Detection of Hepatitis C Virus using peptides from structural and non structural regions, comparison with PCR’, XXXVIII Annual Conference of Indian Society of Gastroenterology held in Hyderabad, India from 6 – 9 November, 1997.

• ‘Prevalence of HBV and HCV in alcoholic liver diseases in Hyderabad’. XXXVI Annual Conference of the Indian Society of Gastroenterology held in Cuttack, India from 2 – 6 Nov 1995.

• ‘Hepatitis B & C infection in Uremics’. XXXIX Annual Conference of Indian Society of Gastroenterology held in Pune, India from 30th Octobr, to 2nd November, 1998.

• ‘Prevalence of HBV and HCV infection in patients with various liver disorder in Andhra Pradesh, South India’. XXXIX Annual Conference of Indian Society of Gastroenterology held in Pune, India from 30th October to 2nd November, 1998.

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REFERENCES
1. Subba Rao
CEO
Biomed Informatics
Medwin Hospital
Hyderabad -500 001

2. Dr. Rekha T.
Clinical Research Officer
Indigene Pharma
Banjara Hills
Hyderabad-68

3 Dr.Madhavi. C
Clinical Research Officer
Deccan College of Medical Science & Allied Hospitals
Hyderabad -500 058

Dr.NAFEESA FAREES

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