Clinical Research Analysis
Resume:
VAISHALI H.
DHAVAN
PERSONAL DETAILS
Phone :
Email:
**************@*****.***
SECTOR EXPERTISE
Clinical Trials
Regulatory
SOP
Analytical Instrumentation
Wet analysis
FDA approved Analyst
KEY STRENGTHS
Hard working, Sincere,
Responsible, Work under
pressure.
PROFESSIONAL SNAPSHOT
Worked as Research Scientist with over 5 years of experience in conducting clinical trials (Safety and Efficacy) individually.
Comprehensive knowledge of Schedule Y, ICH-GCP guidelines, Regulatory guidelines of US FDA.
Comprehensive knowledge of SOP preparation and revision
Approved by Maharashtra FDA in chemical testing and instrumental analysis.
Exposure of two FDA Audits related to Analytical Instrumentation and Chemical testing laboratory.
Experienced in Operation and calibration of Analytical instruments like HPLC, GC, GCMS, UV Spectrometer, Brookfield Viscometers, Karlfisher, pH Meter.
Comprehensive knowledge of Method development and validation.
Comprehensive knowledge of wet analysis.
Effective communicator with excellent relationship management, possess a flexible & result oriented attitude with analytical skills.
Excellent Team player, leadership skills with analytical problem solving skills.
Thorough knowledge of using MS office.
Excellent English communication skill.
EMPLOYMENT CHRONICLE
Worked with KET’s scientific research centre, Mumbai, India in Cosmetology Division as Scientist from August 2010 to September, 2015.
Key Deliverables
Responsible for conduction of clinical trial from document preparation to report finalization.
Handled complete clinical trials including patch tests, skin care studies, oral care studies, perfumes and deodorant studies on human subjects.
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VAISHALI H.
DHAVAN
PERSONAL DETAILS
Phone :
Email:
**************@*****.***
SECTOR EXPERTISE
Clinical Trials
Regulatory
SOP
Analytical Instrumentation
Wet analysis
FDA approved Analyst
KEY STRENGTHS
Hard working, Sincere,
Responsible, Work under
pressure.
Responsible for preparation of protocol, case record form, inform consent form, screening specific form, visit specific form, Recording AE and SAE, final study report and all documents related to the clinical trial.
Follow up of AE/SAE.
Responsible for preparation of presentations for Ethics Committee approval.
Presentations to the sponsors related to trials
Responsible for quality check of all the study documents and clinical data.
Recording and quality check of data in e-CRF
Responsible for complete coordination with study sponsors right from initiation upto closure of study.
Responsible for complete coordination with recruiting agency for recruitment of study subjects and follow up for study visits
Comprehensive knowledge of instruments like Sebumeter, Chromameter, Corneometer, Visoscan, Tewameter,
Mexameter, Vernier Caliper.
Responsible for bio analysis of clinical samples, water sample, herbal products and raw materials.
Responsible for SOP preparation, revision, calibration and operation of Analytical Instruments (GC, GCMS, HPLC, UV sprectrophotometer)
Responsible for Analytical method development and validation.
Comprehensive knowledge of Head space analysis of VOCs
Stability testing of the products.
Comprehensive knowledge of GCMS analysis of fragrances, raw materials, essential oils and interpretation of chromatograms using library.
Invitro sample analysis, Pre clinical sample analysis, post clinical sample analysis with the help of analytical tools like HPLC, GC, GCMS UV Spectrometer.
Qualitative and quantitative analysis of drugs and their metabolites in biological samples.
Preparation of test reports.
Analysis and identification of essential oils with the help of GCMS.
Basic Chemical test for the products from cosmetics and perfumery world according to BIS Guidelines.
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VAISHALI H.
DHAVAN
PERSONAL DETAILS
Phone :
Email:
**************@*****.***
SECTOR EXPERTISE
Clinical Trials
Regulatory
SOP
Analytical Instrumentation
Wet analysis
FDA approved Analyst
KEY STRENGTHS
Hard working, Sincere,
Responsible, Work under
pressure.
Worked with S. H. Kelkar & Co., Mumbai, India in Creative Centre, Analytical Laboratory from March 2010 to August 2010.
Responsibilities handled:
Comprehensive exposure to GC and GCMS analysis of fragrances, raw materials, essential oils, solvents, etc.
Comprehensive exposure to GCMS chromatogram interpretation using Library.
Responsible for Calibration of Instruments.
Comprehensive knowledge of Head space analysis of Flowers, agarbatti, cosmetic and personal care formulations in liquid or solid form.
Worked with Advanced Agrotech Pvt. Ltd., Thane, India in R&D Laboratory from September 2009 to March 2010.
Worked on research project of silver nano-particle formation and incorporation in different products.
Worked on research project of resins for water filtration and purification.
Worked on wet analysis, preparation and standardisation chemicals.
Comprehensive exposure to Hanna Instrument for quantitative silver analysis.
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TRAININGS ATTENDED
Lubrizol India Pvt. Ltd., New Mumbai
Duration: 1 Month Project
Studied variation in viscosity of polymer with temperature
Determined molecular weight of given Polymer
studied FTIR Spectra of Polymer
Determined additive based on FTIR spectra of polymer
GC analysis of solvents.
Attended GCMS training workshop organized by Chromatographic Society of Inida.
ACADEMIC CREDENTIALS
M.Sc in Analytical Chemistry: Qualified for this degree in 2009 from Mumbai University with 1st class
B.Sc in chemistry: Qualified for this degree in 2007 from Mumbai University with 1st class.
Diploma in basic Clinical Research Management and Regulatory affairs, Haffkine Institute.
HSC: Qualified in 2004 from Mumbai University with 1st class.
SSC: Qualified in 2002 from Maharashtra state Board with distinction.
PERSONAL NICETIES
Date of Birth : 07 December, 1986
Nationality : Indian
Marital Status : Married
Gender : Female
Languages known : English, Marathi & Hindi
Visa Status : Residence
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