Clinicalresearcher,Medical writing Resumes in India-Maharashtra-Mumbai City: ashwini

Clinicalresearcher,Medical writing Resume

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Name:

ashwini

Location:

India-Maharashtra-Mumbai City

Experience:

Willing to Relocate:

Willing to Travel:

Most Recent Job Title:

Clinicalresearcher,Medical writing

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Objective:

To make a career in medical research field as an expert in methodology of implementing research projects in accordance to GCP/ICH guidelines

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H guidelines.

Profile:

• Keen sense of clinical research, strong background in medical science
• Trained in clinical research regulatory requirements
• Trained in Good Clinical Practice.
• Trained in protocol writing, writing abstracts and articles for medical journal submission.
• Interested in searching relevant articles to facilitate the on going work of medical writing.
• Organizing journal club paper presentation and presenting papers in journal club paper presentation.
• Conducting and participating in CME programme.
Education:
• M.B.B.S.( 1994 –1999 )
Mahadevappa Rampure Medical College.(MRMC)
Gulbarga, Karnataka.
Registration No. 55674 April 2000(Karnataka Medical Council)
• PDCR. (Professional Diploma in Clinical Research) By Catalyst clinical Services Pvt.Ltd March .2006
• PGDEMS (Professional Diplama in Emergency medicine) From Symbiosis center for health Pune in the year 2004

Experience:
1) Presently working with Quintiles as Clinical research Co-ordinator for a multicenter global clinical trial in Cardiology at Bangalore.
Main responsibilities undertaken here are
• To co-ordinate between the investigators and the CRA
• To check the compliance of the investigator to the study protocol
• Witness the consent process whether it is going on according to the ICH/GCP rules and regulations.
• Maintaining the master file
• Drug accountability
• CRF completion
• Maintaining the source document whether the investigator is completing it in time.
• Co-coordinating with the team leader regarding the study related queries
2)Cipla Chest Research Foundation, Pune. (FEB 2004-December-2005)
Worked as a Research associate /Co-investigator
Clinical Research Work Assignments:
1. A randomized, open-label, non-placebo controlled therapeutic crossover comparative study of Salbutamol delivered by three commercially available spacers (Zerostat spacer, Cipla Ltd., Large volume spacer, Cipla Ltd. and Aerolife spacer, German Remedies) through pressurized metered dose inhaler in four cumulative doses (100mcg, 200mcg, 400mcg, and 800mcg) in adult asthmatic subjects.
Responsibility:Research associate/Co-investigator

2. A 6-week, open, prospective, non-comparative, multicenter, phase III study to assess efficacy and safety of Ciclesonide 200 mcg once daily delivered with pressurized metered dose inhaler in patients with mild to moderate asthma.
Responsibility: Research associate/ Co-investigator/Team leader
3. A randomized, double blind, prospective, single dose, cross over, phase III, placebo controlled study to evaluate safety and efficacy of Levosalbutamol in comparison with racemic salbutamol delivered by pressurized Metered Dose Inhaler p(MDI) in patients with chronic stable bronchial asthma.
Responsibilty –Research associate/ Co-investigator/Team leader
4. A Randomized Double blind, cross over study of tiotropium Bromide+ Formoterol combination (Duova) and tiotropium Bromide (Tiova) alone delivered by a pressurized metered dose inhaler (pMDI) in adults with chronic obstructive pulmonary disease.
Responsibility: Research Associate
5. A therapeutic equivalence and safety study of two Fluticasone Propionate formulations delivered by nasal spray (Innovator versus Generic) in adults with Allergic rhinitis.
Responsibility: Research associate/ Co-investigator/Team Leader
6. .A randomized double blind crossover therapeutic equivalence study of tiotroium bromide delivered by pMDI with zerostat spacer(Cipla) and rotahaler in adults with chronic obstructive pulmonary disease.
Reponsibility: Research Associate. / Co-investigator
g). A randomized double blind double dummy multicentre parallel group safety and efficacy study comparing Formetorol HFA with Formeterol CFC both delivered by PMDI in patients with chronic stable asthma.
Responsibility: Research associate. / Co-investigator
7. A randomized double blind double dummy multicenter parallel group safety and efficacy study comparing Salmeterol HfA with salmeterol CFC both delivered by PMDI in patients with chronic asthma.
Responsiblility: Research associate. / Co-investigator

Academic Projects:
a) Respiratory Health Status of People living in the Slums of a subsection of Pune City (Pilot study).
To test the hypothesis that factors like low socioeconomic status, poor housing facilities, overcrowding and less education status, in slums of Pune city are contributory factors for respiratory morbidity
Responsibility: Research associate/ Co-investigator
b) An open lable, randomized, crossover evaluatory study of effect of mosquito coil inhalation on airway hyper responsiveness and lung function in healthy and mild asthmatic subjects.
To study effects of short term inhalation of mosquito coil smoke on lung functions, symptom scores and airway hyper responsiveness in healthy and asthmatic subjects.
Responsibility: Research Associate/ Co-investigator
C). Actual blows required(FEV1maneuvers)during the bronchial hyperresponsiveness testing.
Responsibility: Study co -ordinator.
d). Randomized double blind cross over design to study 6-Mw distance in patients with chronic obstructive pulmonary disease at baseline, after administration of tiotropium bromide.
Status. Completed
Responsibility: Protocol designing, preparing SOP of 6MWT,CRF designing, site for conducting the test assessment, patients recruitment,
training the technician to conduct the test, data collection.
Duties carried out at Chest Research Foundation, Pune as Research associate / Co-investigator/Team leader
a. Protocol development, CRF designing, Study Designing
b. Patient recruitment
c. Keeping comprehensive information updated and understanding of the respective protocols; protocol related schedule of events and procedures.
d. Ascertain protocol-related requirements, place orders for the same.
e. Conduct counseling sessions with the patient for patient enrolment and explain to them the trial disciplines, obtain their consent.
f. Coordinate the screening investigations and write out a detailed and clear and self- explanatory history of the patient.
g. Schedule patient visits and organize for all routine and specific investigations.
h. Maintain Case record forms and source documents.
i. Respiratory health check-up camps in village level people and occupational surveillance camp in industrial workers.
j. Take active participation in writing research papers, review articles.
k. Conducting power point presentation of the study design, action plan for conducting the trial, assigning the duties to the other involved staff.
l. Co-ordination with the sponsor regarding the study materials.
m) Co-ordination with the administrator in relation with the patient’s transportation, arrangements for the patients stay at CRF, in relation with the compensatory amount payment for the patients.
n) Observing for any SAE and AE during the trial period.
o) Co-ordination with the Principle investigator.
p) Monitoring the academic studies for quality assurance.
q) Conducting field monitoring visits.
r) Active participation in various academic projects.
s) Writing abstracts, preparing posters of original work for presentation in conferences in which I have involved directly.
t) Organizing journal club paper discussion.
u) Presenting papers in journal club.
v) Searching relevant articles online

3) Resident Medical Officer at Manas vardhan mental and de-addiction center, Pune
(Feb 2003-feb2004)
Having experience in Psychiatric medicine.
Responsibility: Treating the medical complaints and minor surgical complaints of the admitted patients.

4) Resident Medical Officer in NICMAR
(November 2002-July 2003)
5) Tutor in the department of physiology MVJ medial college, Channasandra Bangalore.
(December2001-July2002)
6) Resident Medical Officer in Wagad Welfare Society Hospital Bhachau. Katch.(September2000-January 2001).
Experienced in the department of medicine, Department of Ophthalmology, department of orthopedics and department of Surgery.
7) Compulsory rotatory internship (March 1999-march 2000)
Urban Internship- Govt general hospital Gulbarga.
Experimentation Skills:
• Spirometry with Pneumotacograph 2120, Spirolab and VitalographR, 2160.
• Skin prick test for allergy testing, particularly with aeroallergen.
• Impulse ossilometry, body plethysmography.
• PMDI with spacer, rotahalers, Nebulizer, Kokos dosimeters,
• Rhinomanometry.
• Peak nasal Inspiratory flow rate machine
• Wrights peak expiratory flow rate machine.
• Co analyzer.

Special tests conducted:
• Bronchial challenge: Conducted nearly 100 bronchial challenge tests with 5, AMP.
• Skin prick tests
• Nasal challenge tests with 5, AMP

Audit: Faced an audit on 25th of April 2005 for the study “A randomized double blind, prospective, single dose, cross over, phase III ,placebo controlled study to evaluate safety and efficacy of Levosalbutamol in comparison with racemic salbutamol delivered by pressurized Metered Dose inhaler p(MDI) in patients with chronic stable bronchial asthma.” In this project I have served as team leader.
Conferences attended:
1) 10th Biennial congress of the trans- pacific Allergy and immunology Society.Oral paper presentation was given on number of blows required during bronchial challenge.

List of Publications and conference presentations.
1. Jantikar A, Sewlikar S, Bal T, Mandale J, Takavale A, Shaikh A, Salvi S. (2004). Number of blows required during bronchial challenge. For oral paper presentation in 10th Biennial congress of the Trans-pacific Allergy and Immunology Society, 21-23 November 2004, held in Mumbai, India.
2. B.Brashier, A. Jantikar, S. Sewlikar, M. Maganji, T Bal, S. Salvi. (2004). Effect of mosquito coil (MC) smoke inhalation in healthy and mild to moderate asthmatic subjects, NAPCON 2004 Ahmedabad.
3. Jantikar A, Sewlikar S, Bal T, Mandale J, Takavale A, Shaikh A, Salvi S. (2004). Number of blows required during bronchial challenge. Published in “CHEST”2005;128;469-470 DOI :10.1378/chest.128.1.469
4. Ashwini Jantikar, MBBS Bill B Brashier, DTCD, A.Raghupathy, DTCD V.Vincent Trupti Bal and Sundeep, Salvi, MD, PhD”A single dose of tiotropium produces a significant improvement in 6-MW distance in severe COPD subjects.”European Respiratory Society Annual Congress2005. Abstract No. –255918
5. Bill B Brashie, Jyoti Londhe, Ashwini M Jantikar, Manisha Maganji. Trupti Bal, Sundeep S Salvi Clinical research, Chest research Foundation Pune. “Prevalence of Obstructive Lung diseases in 12,043 slum dwellers of Pune city, India” European Respiratory Society Annual Congress 2005. Abstract No-255635.
6. Ashwini M Jantikar Brashier, B. A Raghupathy, Trupti bal, Sundeep salvi.”Levosalbutamol is as effective as in chronic stable asthma, compared to Recemic salbutamol in half the dose.” Respiratory Medicine”
7. Comparison of bronchodilator Responses of Levosalbutamol and Salbutamol given by pressurized metered dose inhaler:A Randomized, Double-Blind, Single-Dose, Study. Jantikar Ashwini,Bill Brashier, Maganji Manisha, Mahadik Purnima, Gokhale Parth, Gogtay Jaideep, Salvi Sundeep.Submitted to ERJ(European Respiratory Journal)
8. Addition of Formoterol to Tiotropium in a single inhaler produces better FEV1 and FVC responses when measured over 24 hours following single dose administration in subjects with COPD.
Brashier B,Jantikar A,Maganji M,Raghupathy A,Valsa S, GokhaleP,Mahadik P,Gogtay JA,Salvi SS
Accepted for poster presentation at ACCP 2005 (October 29th to November 3rd) at Montrial CANADA.
Workshops:
1. GCP Lecture Series: Attended the lectures on Good Clinical Practice held in the month of May and April 2004 at Chest Research Foundation, Pune. Various aspects and guidelines of GCP were covered during the lectures.
2. Spirometry workshop held at Chest Research Foundation, Pune on 05/06/2004.
3. Allergic Rhinitis: Introduction, Etiology, Pathogenesis, Pathology, Medical and Surgical Management, held at Chest Research Foundation, Pune on 21/08/2004.
4. Introduction to statistics. By Mrs. Trupti Bal Statistician, conducted at Chest Research Foundation during the month of October 2004.
5)Atteneded Pharma research Confluence. Which was held In Mumbai, 24-26 Feb 2005 by well-known Pharma companies
6) Trained in GOI/WHO collaborative project on Development of SOPs Guidelines, Training modules for Good Clinical Practice (GCP) Programme for new drug clinical trials, Organized by Department of clinical Pharmacology TNMC and BYL Nair ch.Hospital at Mumbai 29th to 30th April, 2005.

Other Achievements:
o 80% in Class X in Karnataka State Board (Science 92%, Mathematics 99%)
o 83% in Class XII in Karnataka State Board (PCB: 85%, PCM: 82%)

Extracurricular activities:
• Won many prizes in debate competitions.
• Won first prize in district level competition in stage monoacting.
• Participated in inter school sports competition.
Computer Skills:
o Microsoft word.
o Microsoft excel.
o Microsoft power point.
o Internet explorer

Reference:

1) Dr S.Salvi MD Phd(UK)

The Director, Chest Research Foundation,
Vadagoan sheri, Kalyani nagar, Marigold premises
Pune;020-27035361/71 09372405352
2) Dr.M.R.Kulkarni MS Gen. Surgery
Medical director
Bhagwan Mahavir jain Hospital
Bangalore,Mobile-9845258283
3)Dr. Sarvottam Rao B.MD Obstetrics and Gynaecology
Professor Dept of OBG
MRMC Gulbarga
Matruchaya Nursing home
Khuba Plots Gulbarga
(08472)222154

(Dr.Ashwini M. Jantikar) Date05/05/07

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