Quality Control Medical

SUBBULAKSHMI (SUBBU)

GNANASAMBANDAM

Email:

abii0u@r.postjobfree.com

*** ******

Blvd,

King of

Prussia, PA -

19406

Phone: 267-777-

8529

OBJECTIVE

To pursue a challenging career in the field of scientific research by being

a part of a progressive organization that gives me an opportunity to

contribute to an exciting effort and enhance my skills.

SKILLS

Summary

. Experience in Clinical Data Management, Internal Quality Control

Audit, SOP and study protocol maintenance

. Clinical research regulatory affairs experience, involved in reporting

Serious Adverse Events (SAEs) for Clinical studies

. Experience in Fibroblast cell culture

. Experience in Quality control tasks in research lab techniques.

. Organized and Coordinated Medical camps for Oncology trials

. Performed Biochemical, hematological and Immunological tests.

Experience in Flowcytometry and Mass Spectroscopy

. Involved in the Case report form and Informed Consent form designing,

Ethics committee, and Patient recruitment for Oncology and other

Clinical trial projects

. Experience in Clinical administration and budget management

. Animal dissection experience

Clinical trials

. Involved in the Case Report Form (CRF) and Informed Consent form

generation.

. Involved in Ethics Committee (Institutional Review Board) for the

approval of the projects.

. Coordinated Medical camps for patient recruitment.

. Performed Clinical data validation and Quality review

Clinical Administration

. Managed Clinical areas of Patient care, adverse event records,

research lab tests and data validation, Medical camp coordination and

patient recruitment, documentation of patient requisition form,

slides, confidential data/files, SOPs.

. Assisted Medical director in the budget management.

Quality Assurance/ Quality Control

. Maintained lab equipments in sterilized condition, prepared

sterilization protocol and maintenance record. Performed instrument

calibration for quality result.

. Had run Quality Control samples from CAP (College of American

Pathologists) for General Hematology survey and UK NEQAS (United

Kingdom National Quality Assessment Service) samples for CD4 CD8

Cells. Quality control samples from BIORAD have been run to maintain

the quality of the daily hematology reports.

Regulatory Affairs

. Prepared study protocol, Case Report Form, Informed Consent Form for

IRB (Ethics committee) submission.

. Has been a member in Internal Review Board and prepared meeting

minutes of all board meetings

. Prepared technical document for QC audit in clinical data management.

. Maintained study protocol, SOP, work procedures of many studies,

written Serious Adverse Events for Clinical studies

. Maintained confidential files of patients for follow-up studies

Immunology

. Performed CD4/CD8 cell count using FACS Count (Becton Dickinson -USA),

using Dynabeads T4-T8 System (Dynal Biotech, Norway) and Manual count

(Beckman Coulter, USA).

. Performed CD4 cell count using Personal Cell Analyzer from Guava

Technologies -USA

. Performed ELISA for Viral load determination using ExaVir Load -

Quantitative HIV-RT Load kit.

. Performed Western blot technique as a confirmatory test for HIV/AIDS

Hematology and Biochemistry

. Performed hemogram using MEDICON 4000, Germany.

. Performed Biochemical tests using STATFAX 2000, semi-automated

instrument and Mass Spectroscopy

Flow cytometry

. Had run > 2000 HIV/AIDS blood samples in Flow cytometer to determine

the Immune status of the patients

Cell culture

. Standardized Fibroblast culture from oral biopsy tissue samples of

Oral sub-mucous fibrosis patients.

Protein Purification

. Performed Chromatography to indentify the aminoacids and Gel

Electrophoresis to identify the protein

RESEARCH LAB EXPERIENCE

Clinical Data Coordinator - ICON CLINICAL RESEARCH, India March 07 to

Dec 08

. Involved in the clinical data management of Multi center, Phase

II/III, Randomized, Double-Blind, Placebo-Controlled studies to

determine the clinical efficacy and safety of the drug

. Performed clinical data validation according to the inclusion and

exclusion criteria of the study based on the edit checks for Phase II

/ III clinical studies.

. Performed Query / Data Clarification Form generation of clinical data

discrepancies

. Data Clarification form update based on Investigator's reply

. Involved in the quality review of clinical data.

. Study lead for clinical data validation of Phase III/ multi centered

studies and provided study specific trainings

. Lead for Internal quality audit team. Prepared technical documents for

the internal quality audit for the proper maintenance of SOPs, Work

Procedures, Study specific training documents, control documents.

. Performed Internal quality audit

. Involved in the sponsor's audit/ ISO audit.

. Achieved good productivity of work with good quality before deadline

(eg. resolved more than 35000 discrepancies).

. Mentored many people regarding the workflow, control documents

maintenance, Standard Operating Procedure (SOP) maintenance

confidentiality maintenance of the company.

. Involved in the PASS/FAIL Edit check specifications.

. Involved in metrics management of Clinical Data Coordination team.

. Provided study specific training to the team members and ensured that

the team produced high quality of work.

Research Assistant - CHENNAI DENTAL RESEARCH FOUNDATION, India Aug 04 to

March 07

. Involved in the Standardization of Fibroblast culture from oral

tissues of Oral submucous fibrosis (OSMF) / Oral cancer patients and

lymphocyte culture from blood, according the research laboratory

protocol.

. Involved in Case Report Form, informed consent for generation, Patient

recruitment, Clinical administration, IRB member, site monitoring,

Study protocol development, Questionnaire administration for oncology

projects.

. Performed study to evaluate the difference in the micronuclei count in

saliva sample between the tobacco chewers and the non-chewers in a

community.

. Performed regulatory affairs of clinical trials, Adverse Events

reporting, lab techniques according to standardized protocol. Meetings

with Medical director and research assistants about the study flow.

. Involved in the questionnaire generation and administered in

adolescent population to evaluate their nutrition levels

. Performed a community-based study about the knowledge on HIV/AIDS

among urban slum adolescents

. Conducted camps in a fishermen community to assess their salivary flow

rate of the diabetic and non-diabetic people in collaboration with M.V

Diabetes, Royapuram, Chennai

. Coordinated Oral health screening / cancer awareness camps in

collaboration with Colgate 'Smile care' project in various schools

Research Assistant - YRG CENTRE FOR AIDS RESEARCH & EDUCATION, India

Jul 02 to Feb 04

. Executed complete blood analysis using MEDICON - 4000 (an automated

instrument), CD4 / CD8 cell count using FACS Count and generated

report on daily basis for HIV/AIDS patients.

. Performed complete blood count, urinalysis and CD4/CD8 cell count,

generated reports for >2000 HIV/AIDS patients

. Performed the determination of HIV Viral load using ExaVir Load,

Quantitative HIV-RT Load kit - an ELISA based technique (Low cost HIV

monitoring assay). Worked on NIH funded projects.

. Involved in the documentation and filing of Lab manuals, SOPs and

quality control maintenance chart.

Volunteer - HENNEPIN COUNTY MEDICAL CENTER (HCMC) Minneapolis, MN, USA

. Clinical administrative support in Cytology lab

. Filing patients requisition forms

. Arranging Laboratory slides in Cytology and Histology departments

RESEARCH TRAINING

Have undergone Forgarty International training program at Macfarlane

Burnet Institute for Medical Research and Public Health, Australia for low

cost HIV monitoring assays.

. CD4 T lymphocyte determination using Dynabeads T4 - T8 System (Dynal

Biotech, Norway) and Coulter Manual count (Beckman Coulter, USA).

. Viral load determination using ExaVir Load, Quantitative HIV-RT Load

kit (Cavidi Tech, Sweden).

PUBLICATIONS

. Balakrishnan P, Dunne M, Kumarasamy N, Crowe S, Subbulakshmi G, Ganesh

AK, Cecelia AJ, Roth P, Mayer KH, Thyagarajan SP, Solomon S. An

inexpensive, simple, and manual method of CD4 T cell quantitation in

HIV infected individuals for use in developing countries. Journal of

Acquired Immune Deficiency Syndrome; 2004 August 15th; 36(5): 1006-10.

. Gunaseelan R, Sowmya R, Shanthi S, Prem Deepa, Amrita D, Subbulakshmi

G. Quantitative assessment of unstimulated Salivary Flow rate by

diabetes status in fishermen community in Chennai. Journal of Indian

Association of Public Health Dentistry, Volume: 2006(7), 53-58.

. Gunaseelan R, Sowmya R, Amrita D, Shanthi S, Subbulakshmi G. A

community based study on HIV / AIDS knowledge among urban slum

adolescents. Journal of Indian Association of Public Health Dentistry,

Volume: 2006(7), 63-69.

EDUCATION

. Masters of Science in Bioinformatics (MSc) - December 2005

Annamalai University, India

Emphasis: Proteins and Nucleic acid Biochemistry, Biophysics and

Structural biology, Bio-statistics, Cell biology, Molecular Biology and

Genetic Engineering, Genomics and Proteomics, Molecular Modeling and drug

designing. Minor: Immunology

. Post Graduate Diploma in Medical Laboratory Technology (PGDMLT) - May

2002

Loyola Institute of Vocational Education (LIVE), Loyola College.

Emphasis: Human Pathogens, Hematology, Clinical Pathology and Human

Anatomy, Medical Laboratory Instrumentation and Biochemical analysis

. Bachelors of Science in Biochemistry (BSc) - October 2001

University of Madras, India

Emphasis: Bio-organic Chemistry, Biophysical chemistry, Enzymes and

intermediary Metabolism, Analytical methods in Biochemistry, General

Physiology and Nutritional Biochemistry, Macromolecular Biosynthesis and

Clinical Biochemistry. Minor: Chemistry and Biology

PGDMLT PROJECT

. Pertinent Study on Hemogram

The Project involved screening of school students for Blood Pressure,

Pulse Rate, Packed cell Volume (PCV), Erythrocyte Sedimentation rate

(ESR), Red Blood Corpuscles (RBC) Count, White Blood Corpuscles (WBC)

Count, Differential Count and Urine Sugar Level. Students of the school

were screened during a medical test project camp held in March 2002.

Based on the reports the students were counseled and the necessary

guidance was provided for the maintenance of good health

CERTIFICATION

. Human Subject Research Education of Johns Hopkins School of Hygiene and

Public health at YRG CARE (Jul 2003)

SYMPOSIUM

Participated in a Symposium on Prognosis and Diagnosis of recent Epidemics

in TamilNadu, India - A Review

FAMILIAR LAB EQUIPMENTS

. FACS Count (Flowcytometer), MEDICON 4000 (Hematology analyzer), STAT FAX

2000 (Biochemical analyzer), Autoclave, Bio-safety cabinet, Microscopes,

CO2 incubator, Deep freezers, Multi Channel pipettes, Reverse pipette,

centrifuge, Hot air oven, ELISA plate and reader, Automated ESR measuring

instrument, Personal Cell analyzer (PCA) for CD4 cell count.

REFERENCES: Available on request

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