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Clinical Research

Location:
Mumbai, MH, India
Posted:
May 09, 2014

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Resume:

Sajitha Kiran Unnikrishnan

Powai, Mumbai – *** **6 (India).

Mobile: +91-900*******

Mail: acd2ge@r.postjobfree.com

Dear Sir/Madam,

I am a Post-Graduate in Medical Bio-Chemistry and Bachelor of Science in Zoology (Honors). My

education is coupled with experience of dissertation in specialized fields and gained with live seminars. I

have total 6 years of work experience and I am currently working as Senior Clinical Research Associate in

Hindustan Unilever Ltd (FMCG), Mumbai

My experience has helped me to acquire a set of dynamic skills that have been listed and elaborated in my

Resume. This should give you the reason to invest in my capacities and abilities.

I feel that your organization offers a professional environment and the right kind of career prospects

interlaced with challenging opportunities to an enterprising professional like me. I also bel ieve I possess all

the abilities to make a major contribution in attaining your Organization’s goals. I eagerly look forward to

developing a long and successful career with you.

Thank you for considering my application.

Sincerely,

Sajitha Kiran Unnikrishnan

# Enclosed: Resume

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Sajitha Kiran Unnikrishnan

Powai, Mumbai – 400 076 (India).

Mobile: +91-900*******

Mail: acd2ge@r.postjobfree.com

Objective

To work in a challenging environment that would utilize as well as enhance my abilities.

Scholastic Profile

Certificate in Clinical Research (6 months), 2009, Symbiosis Centre of Healthcare, Pune, INDIA

Master of Science in Medical Bio-Chemistry, 2006 ( Dissertation submitted - “Topic” – Dyslipidaemia in

Chronic Renal Failure Patients) - 4 years course, Vadodara Medical college, SSGH, M.S.University, Baroda

(Gujarat), INDIA

Bachelor of Science in Zoology (3 yrs-Honors), 2002, Maharaja Sayajirao University, Baroda (Gujarat),

INDIA. Sub: Zoology, Botany & Chemistry.

Achievements

Achieved R & D Award certificate for the Product launch and market go strategy in April 2014, at Hindustan

Unilever ltd. Mumbai.

Recognized and listed as highest performer in 2012 in clinical research team, at Hindustan Unilever ltd.

Mumbai.

Received Best office award and regional award for achieving quarterly targets in company, AIMIL Baroda

(Gujarat, India)., 2006-2007.

Has done poster presentation in First National Medical Students Research Conference, held at Moving

Academy of Medicine and Biomedicine, Pune (Maharashtra, India). in October 2006.

Attended workshop on laboratory methods in Inborn Metabolic Di seases conducted by Department of

Biochemistry at Smt. NHL Municipal Medical College, Ahmedabad (Gujarat, India) in January 2006.

Participated in the two day seminar on Modern Biology : Facets and Prospects organized by Department of

Biochemistry, the M.S. University of Baroda and Tata Institute of Fundamental Research, Mumbai in October

2005.

Attended 31st Annual National Conference of Association of Clinical Biochemistry of India, held at J.N.

Medical College, Belgaum, Karnataka in December 2004.

Has attended the Pre-conference Workshop on Molecular Diagnostic Techniques as a part of ACBI

conference held at J.N. Medical College, Belgaum, Karnataka in December 2004.

Won Gold medal (singles) and Silver medal (mixed doubles) in carrom, Annual Vibrant Event, 2005 Baroda

Medical College (Gujarat, India).

st rd

1 in English Calligraphy in 1995 &1996 and 3 in Hindi Calligraphy in 1995.

Work Profile

#1

Current Job title - Senior Clinical Research Associate, Clinical research Department

Organization - Hindustan Unilever Ltd.,

Location - Mumbai (Andheri), India

Principal Organization – Unilever Global

Job Duration - 15th June 2009 till present

ROLES AND RESPONSIBILITIES:

Interfacing with internal research & development, regulatory departments and key stakeholders to move the

clinical project. Acting as the main line communication between the Sponsor and the Principal Investigator

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Sajitha Kiran Unnikrishnan

Powai, Mumbai – 400 076 (India).

Mobile: +91-900*******

Mail: acd2ge@r.postjobfree.com

Training third party study site on Study protocol, study execution and study execution documents. Ensure all

project/study team members understand project goals and objectives, the project plan/schedule, and critical path

activities.

Involved in conducting and managing clinical studies cross category for Oral (toothpastes), Hygiene (soap bar and

liquid handwash) and Skin (face creams) at internal as well as external (third parties) clinical study sites.

Liaison with CRO /third parties (Clinical research organizations, Recruitment agency, external laboratories,

Dentists, Dermatologists, consultants) to ensure project deliverables and deadlines are met.

Writing and designing clinical study protocol and study design in partnering with the Global clinical team

Liaison with the Ethics committee to obtain the ethics clearance on the clinical study.

Coordinating resource planning and Man hour costing with the third party CRO for the feasibility of the study.

Develop periodic project status reports; provide timely communication of project status, changes, risks, and issues

to the project team and key stakeholders.

Writing study briefs, study protocol, documentation for ethics committee submission, protocol amendments,

Informed consents, study networks, user guides, SOPs, study execution documents, study reports

Contributing in developing training modules, SOPs and monitoring process flows to enhance the quality of clinical

study execution.

Monitoring and coordinating the study at external CRO as per agreed timelines and as per ICH -GCP guidelines.

Communicating deviations from the protocol, SOPs, GCP, and the applicable regulatory requirements to the

investigator and taking appropriate action designed to prevent recurrence of the detected deviations.

Building and implementing QC system at the external study site.

Handling various clinical Instruments like Konica Minolta spectrophotometer CM2600d for skin colour

assessment, Skicon 200 EX, Corneometer CM825 & Tewameter for assessing skin surface moisture, VISIA

for face imaging, Halimeter for Oral Malodour detection.

Developing user guides/SOP for establishing processes & systems for attaining accuracy in different

Instrumental evaluation tests

Training the external instrument operators on the clinical instruments.

Beyond Clinical work –

Represented HUL at world dental care workshop in the year 2009.

Actively participated in consumer home visits as a part of CTI (Consumer Technical Insight) work

#2

Designation - Life Scientist, Life Sciences Department {Clinical Chemistry Section},

Organization - Randox Laboratories (India) Pvt. Ltd,

Location - Mumbai, India

Principal

Organization - Randox Laboratories Ltd. (UK)

Job Duration - 02 July 2008 to 30 May 2009

Roles & Responsibilities:

Validation of semi automated and fully automated clinical diagnostic Instruments .

Validation of (USFDA approved) assigned projects for clinical diagnostic assay development.

Development of new products. The continual improvement and assessment of existing products.

Coordinating with customers in the evaluation of new products. Troubleshooting of queries (internal &

customer related) in conjunction with the technical support department.

Preparation of specification for the procurement of chemical reagents, instruments & equipment.

Evaluation of new raw material and the competitor product.

Maintenance of stock material and chemicals.

Scientific documentation of assigned projects.

#3

Designation - Application Specialist

Organization - AIMIL Ltd. (Instrumentation & Technology),

Location - Baroda (Guj), INDIA

Principal Organization – UK Malvern Instruments Ltd.

Job Duration - 18 January 2007 to 30 November 2007

Roles & Responsibilities:

Co-ordinate with Branch Head / VBT Head, Head Office, other Branches etc. for effective inter -office

communication

Co-ordinate with Overseas Principal Organization.

-3-

Sajitha Kiran Unnikrishnan

Powai, Mumbai – 400 076 (India).

Mobile: +91-900*******

Mail: acd2ge@r.postjobfree.com

Visit customer sites to resolve application / analysis related queries

Perform Qualitative and Quantitative analysis using the science of sampling, defining, isolating, concentrating

and preserving samples, set error limits, validate and verify results through calibration and standardization

perform separations based on differential chemical properties; create new ways to make measurements;

design SOP’s (Standard Operating Procedures); interpret data in proper context; and communicate results

Handling MALVERN INSTRUMENT (UK) made Analytical Instruments like Laser Diffraction S ystem

(Mastersizer 2000S) and Photon Correlation Spectroscopy System (Zetasizer Nano ZS).

Effective communication and Maintenance of Record.

Computer Proficiency

Clinical study Instrument software for skin colour measurement and skin surface hydration measurement

Microsoft office tools as Excel, Word, Power Point and others.

Analytical chemistry software version 5.0 in Particle size analyzers.

Clinical chemistry software for spectrophotometric assays and coagulation assays.

Documentation in V5 template and Evaltool excel sheet programme for analyzing the recorded data.

Acquainted Techniques

.

Clinical Biochemistry Techniques / Spectrophotometric assays : Performing Lipid Profile Test, Kidney

function Test, Liver function Test, Gastric function Test, Thyroid Hormo ne test By ELISA technique,

Creatinine clearance test by manual method on semiautomated spectrophotometric analyzers.

Handling various instruments like Konical Minolta spectrophotometer, Skicon 200 EX, Corneometer

CM825, Tewameter,Semiautomated Spectrophotometer - Erba, Microlab 200, Colorimeter, Ph meter, Blood

Gas Analyser,Centrifuge, Flame Photometer, ELISA reader

Professional Training :

Training at Hindustan Unilever Ltd On – Clinical Research methodologies/instruments :

A) Handling various clinical Instruments like Konica Minolta spectrophotometer CM2600d

for skin colour assessment, Skicon 200 EX, Corneometer CM825 & Tewameter for

assessing skin surface moisture, VISIA for face imaging, Halimeter for Oral Malodour

detection.

B) Carried out Clinical studies in various categories like Oral Hygiene (Toothpastes), Soap bars

(Cleansing), Skin care (Face creams).

C) Carried out various type of clinical studies like antigingivitis/gum care studies, plaque removal

studies, tooth whitening studies, cup scrub studies (with ASTM methodology), skin colour and

spot colour lightening studies, skin surface hydration assessment studies, patch studies, Instant

appearance benefit studies, Self assessment studies

D) Documentation - Preparing study briefs, study protocol, documentation for ethics committee

submission, study networks, user guides, SOPs, study execution documents, study reports

Training at Randox Laboratories (India) Pvt. Ltd. Lab On – Clinical chemistry techniques :

A) Handling various Clinical Diagnostic Instruments like Rx Daytona which is a fully automated

Random access analyzer, Microlab 300, UV Spectrophotometer Shimadzu, Electronic Weighing

Balance, Coagulation analyzers – Stago Start 4 and Thromboscreen, pH meter, Autoclave,

Labconco Lyophilizer.

B) Carried out various coagulation assays (Haemostasis) following GLP techniques – Manual tilt

tube method, PT Assay, aPTT Assay, coagulation factor assay like Antithrombin III and

Spectrophotometric assays determining biochemical parameters in “ invitro” lab conditions.

C) Documentation - Preparing scientific document of performed experiment, preparing Design

assay specification, Design output reviews, Technical review studies.

Training at AIMIL Ltd. Lab On – Analytical chemistry techniques :

A) Handling various Analytical Instruments like Laser diffraction system (UK MALVERN

INSTRUMENTS MADE MASTERSIZER 2000), Photon correlation spectroscopy system (UK

MALVERN INSTRUMENTS MADE ZETASIZER NANO ZS), Ph Autotitrator for particle size

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Sajitha Kiran Unnikrishnan

Powai, Mumbai – 400 076 (India).

Mobile: +91-900*******

Mail: acd2ge@r.postjobfree.com

analysis of API drugs, pigments, dyes, minerals, food products, pharmaceutical suspensions,

and nano substances.

B) Carried out various Laboratory techniques like Particle size analysis of wide range Industrial

products & API samples, designing SOP, zeta potential analysis by ph oton correlation

spectroscopy system, micron size analysis of samples by laser diffraction system applying wet

and dry method for sampling, preparing detailed standard sample report, analyzing particle

shape and size under microscope.

C) Documentation - Preparing SOP (Standard Operating Procedure) of performed experiment,

preparing Retail invoice & Performa invoice of performed test (on paid basis) for customers,

maintaining a track of sales order processing

Personal

Gender Female

Marital Status Married

Nationality Indian

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