Quality Assurance Medical

SMITHA GOPAKUMAR, MBBS

**-** **** ******, *** # 1G

Phone: 646-***-****

Woodside, NY 11377

***************@*****.***

EDUCATION

Bachelor of Medicine and Surgery (MBBS)

Sept'94- Dec'00

Medical College Thiruvananthapuram (TVPM)

University of Kerala, India.

WORK EXPERIENCE

Clinical Research Coordinator- Hospital for Special Surgery

Jun'12-present

Dept. of Medicine (PI Dr. Linda Russell)

Project:

Perioperative Ischemic Evaluation-2 Trial (Poise-2 Trial): A large,

international, placebo-controlled, factorial trial to assess the impact

of clonidine and acetylsalicylic acid (ASA) in patients undergoing

noncardiac surgery who are at risk of a perioperative cardiovascular

event.

Job Responsibilities:

. Work in a team environment and overall coordination of the project:

develop, implement and manage the clinical study.

. Patient screening, enrollment and interviews.

. Medical records abstraction from medical charts and databases.

. Submission and maintenance of regulatory documents and

preparing/submitting IRB applications.

. Adverse event reporting.

. Manage queries, reports, internal database and contribute to quality

and accuracy.

. Work independently and supervise the work of junior coordinators,

provide training and mentoring.

. Develop site training materials and conduct regular in- service to

peri-operative hospital staff.

. Active participation in departmental grand rounds and journal clubs

and assist in medical writing.

. Communicate effectively with various departments in the hospital to

coordinator the functioning of the different aspects of the study once

a patient is enrolled.

Senior Clinical Research Coordinator- Mount Sinai School of Medicine

Oct'08-Jun'11

Dept. of Anesthesiology (PI Dr. Silverstein)

Projects:

. Association of mRNA Stress Genes with Perioperative Vulnerability and

Outcomes in Elderly Surgical Patient (lead coordinator)

. Perioperative Ischemic Evaluation-2 Trial (Poise-2 Trial): A large,

international, placebo-controlled, factorial trial to assess the

impact of clonidine and acetylsalicylic acid (ASA) in patients

undergoing noncardiac surgery who are at risk of a perioperative

cardiovascular event.

(lead coordinator)

. Perioperative Cognitive Protection- Dexmedetomidine and Cognitive

Reserve -Randomized double blind study to evaluate the cognitive

protection of dexmedetomidine in elderly patients.

. Impact of intraoperative Blood Pressure on Cognitive Performance in

patients with and without Hypertension- a prospective observational

study

. Tailored patient management guided with absolute Cerebral Oximetry to

prevent Neurocognitive injury in elderly Patients undergoing cardiac

surgery

Job Responsibilities:

. Conducting Double blind clinical trials

. Isolation of human monocytes for microRNA study

. Liason between bench research and clinical research

. Administration of study drug and monitoring patients in OR

. Administering Psychometric battery to assess cognitive impairment,

mental status, pain, sleep and delirium in study patients of varied

age groups esp. Geriatric patients.

. Carry out clinical study, including preparing IRB/GCO submissions,

regulatory filing, data collections, patient recruitment, reporting of

Adverse Events and Serious Adverse Events.

. Designing Clinical Research Forms (CRF) and devising Standard

Operating Procedure (SOP) for clinical research protocols.

. Training new coordinators

. Troubleshooting and coordinating studies with collaborating centers.

. Phlebotomy and preparation of specimens for repository

. Quality assurance and audit of IRB projects

Clinical Research Coordinator- Columbia University

Sept'07-Oct'08

Dept. of Ophthalmology (Drs. Allikmets and Smith team)

Projects:

. A Genetic Study of Age-related Macular Degeneration

This study aims to determine the genes relevant to Age-Related Macular

Degeneration.

. Genetics of Early Onset Inherited Eye Disorders

This study aims to uncover the genetic factors underlying inherited

eye diseases.

. National Ophthalmic Genotyping Network, Stage 1 - Creation of

Repository for Inherited Ophthalmic Diseases

The purpose of this research is to identify the genetic factors responsible

for causing eye diseases. Working toward this goal, the eyeGENE network is

creating a repository from patients with inherited eye diseases. Ten

laboratories from around the country are participating in this project

Job Responsibilities:

. Coordinate activities between sponsors and investigators and IRB

. Initiate correspondence with IRB, prepare IRB/GCP submissions,

. Maintain and ensure availability of study correspondence and documents

in chronological order for the sponsors

. Performs primary data collection for clinical studies and also

regulatory filing, collecting data and laboratory specimen, reporting

Adverse Events,

. Determine the eligibility of patients for the genetic study and

provide Genetic Counseling if required

. Maintain the database of subjects in compliance with HIPAA

. Process specimens for DNA testing

. IRB Audit

Postdoctoral Fellow - Mount Sinai School of Medicine

June'06-Sept'07

Dept. of Genetics and Genomic Sciences (Dr. Desnick's lab)

Projects:

Developing novel Bone Marrow Transplantation Therapy in KI Mouse Models of

Congenital Erythropoietic Porphyria (CEP)

. Determine percentage of wild type erythroid UROS Activity Needed for

Correction of CEP in the knock in mouse models

. Evaluate the Role of Non-Erythroid UROS activity

. Understand the Role of Housekeeping Gene in CEP

. Characterize the erythroid versus hepatic contributions of UROS

activity to CEP phenotype

. Organ perfusion, isolation, homogenization and HPLC based enzyme

assays

Presentation:

Bone Marrow Transplantation Therapy in Mouse Models of Congenital

Erythropoietic Porphyria (CEP)

Research Technologist - St. Jude Children's Research Hospital

Jul'05 - April'06

Dept. of Genetics (Dr. Grosveld's lab)

. Cloning knock in construct to create Alveolar Rhabdomyosarcoma (ARMS)

animal model

. Gene targeting on ES cells with knock in constructs

. DNA cloning, colony hybridization, PCR and southern hybridization of

genomic DNA

. Maintenance of mouse colonies

Presentation:

Cloning of knock in construct for the ARMS animal model.

Senior House Officer-Sri Uthradam Thirunal Hospital

Dec'00-Dec'01

Dept of Internal Medicine (Dr. K. P. Paulose)

. Clinical management of OP, IP and ICU patients

. Carried out clinical work up and management of type I diabetes mellitus

. Worked on Phase IV clinical trial of a hypoglycemic agent in patients

with newly diagnosed

Type II diabetes mellitus

Presentation:

Coronary Artery disease in Type 2 diabetes Patient

Resident Internship (Clinical Clerkship) - Medical College

Thiruvananthapuram Dec'99-Nov'00

PUBLICATION AND POSTERS

. The National Eye Institute Visual Function Questionnaire in the

Macular Telangiectasia (MacTel) Project.

Invest Ophthalmol Vis Sci. 2008 Oct;49(10):4340-6. Epub 2008 Jun 27.PMID:

18586874 [PubMed - indexed for MEDLINE

. Lagutina IV, Pritchard C, Gopakumar S and Grosveld G.

A versatile mouse model of human alveolar rhabdomyosarcoma (ARMS).Oral

presentation, 2007 FASEB Summer Research Conference, Skeletal

Muscle Satellite and Stem Cells, Indian Wells, California

SKILLS

Clinical Research:

. Abstracting, assembling and organizing research data while monitoring

the clinical course of patients entered onto research protocols

. Interaction with patients and families in a sensitive and empathetic

manner

. Overseeing data validity and ensuring compliance with regulations

. Administering Psychometric battery to assess cognitive impairment,

mental status, pain, sleep and delirium in study patients of varied

age groups esp. Geriatric patients.

. Review non serious ADE; report and review serious AE.

. Prepare fliers and poster for promoting the study.

. Review of medical journals and literature for designing new study and

modify existing study.

. Preparing research summary for the weekly newsletter and coordinating

with satellite centre and trouble shooting their complaints.

. Conducting IRB audits and responding to queries in a timely manner.

Laboratory Research:

. Gene targeting of ES cells

. Southern analysis of genomic DNA

. Cell isolation and transplantation of mouse bone marrow

. Isolation of human monocytes for microRNA studies

. HPLC based coupled enzyme assays and ELISA assays

. Fluorescence microscopy for immuno-histochemical studies and Image

analysis

. Other Molecular Biology techniques like gel electrophoresis, DNA

cloning,colony hybridization of genomic DNA, DNA isolation,

purification and PCR

. Sterile tissue culture techniques

. Maintenance of mouse colonies- breeding, weaning,, irradiation and

necropsy and organ perfusion, isolation and homogenization

. Overseeing laboratory logistics and functioning in compliance with

standard operating procedure

. DNA sequencing and analysis to detect genetic variant

Clinical:

. Training in the clinics in various departments during medical

curriculum and clinical clerkship

. Specialized training in diabetics management and independent patient

care in the department of Internal Medicine.

Computer:

. Windows and Mac platforms

. Metavue for image acquisition and analysis

. Microsoft Office Suite

. Data analysis and application of biostatistical methods using

software

Language:

English, Hindi, Malayalam, Tamil, Sanskrit

Work Authorization:

Applied for change of status (I-485); employment authorization document

(EAD) is approved.

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