SUMMARY

- Energetic and enthusiastic professional.

- Highly organized and efficient in multi-tasking.

- Effective leader, skilled and passionate in Engineering and Clinical

Research

Career Objective: To excel in my field of activity and add value to self

and my organization

Educational Qualification:

- Master of Science in Clinical Research (MSCR), Medical University of

South Carolina, 2011-2013.

- Bachelor's in Biomedical Engineering [60 % Electronics and 40 %

Medicine] (B.E), PSG College of Technology, 2007 - 2011.

Technical Expertise:

- Electronic Data Capture(EDC)- WebDCU, RAVE iMedidata, InForm, EPIC,

RedCAP, OACIS, SAS, MATLAB, LabVIEW.

- Microsoft Office 2007,2010 and various IT and data handling and

processing software .

- Computer proficiency includes programming languages such as C, C++.

- A good team player and organizer of many symposiums and conferences,

with excellent Interpersonal and Administrative skills.

Certifications:

- CITI Certified - Biomedical,HIPAA and GCP

- IATA Certified

- Fellowship in Clinical Research Ethics

- Core Clinical Research Training

- OSHA Training

- Protecting Introduction to MEMS

- ISO 9001:2008 Certification

- Introduction to Biometrics

- Radiation protection in medical technology

- Advanced Digital System Design using FPGA and CPLD

- Introduction to Mass Biospectroscopy

EMPLOYMENT

Clinical Research Coordinator - December 2013 -Present

- Supervised by David C. Weisman, MD, Email: acf2f0@r.postjobfree.com,

Abington Neurological Associates, Ltd.

Responsibilities:

- Screening and enrolling subjects in studies and managing their

participation according to ethical, regulatory, and protocol-

specific requirements.

- Obtaining informed consent and a PHI Authorization (HIPAA) from

trial subjects before performing any study related procedures.

- Developing organizational aids and checklists to facilitate patient

recruitment and the collection of complete and accurate study data.

- Maintaining the regulatory and study files for each research

project.

- AE's and SAE's Reporting.

- Communicating with the IRB as appropriate.

- Assuring proper handling of the investigational product.

- Meeting with sponsor representatives to discuss planned and ongoing

studies.

- Overseeing study closure and reporting of results.

- Participating in quality assurance activities of the sponsor, the

FDA, other regulatory and accrediting agencies and UC's office of

Compliance and Regulatory Affairs.

- Supervising other clinical research personnel, as appropriate.

- Participating as appropriate in the training of individuals

recruited as members of the research team.

- Managing the business aspects of studies, including developing and

negotiating study budgets and, in conjunction with the Office of

General Counsel East, facilitating the contract review process to

assure that provisions on publication, intellectual property,

indemnification, records retention, and data ownership are

appropriately negotiated with the sponsor.

- Design appropriate recruitment strategies and track study

enrollment.

- Proper handling of and accurately processing samples (such as blood

and tissues)

Research Coordinator and Management Trainee - November 2013 - December

2013 (1 Month)

Supervised by Mr. Sivakumar Jayabalan PhD, CEO - Aiyan Diabetes

Center, Email: acf2f0@r.postjobfree.com

Responsibilities:

- Manager and coordinator for cross-functional project teams.

- Developed study related plans.

- Timely submissions to the regulatory board.

- Attended Investigator meetings.

- Prepared and presented project information.

- Ensured consistent use of study tools and training materials.

- Implemented continuous improvements in assigned projects.

Clinical Research Engineer - July 2013 - August 2013 (1 Month)

Supervised by Ms. Heather Knight, Lead Engineer, Email:

acf2f0@r.postjobfree.com, College of Health Professions, Medical University of

South Carolina

Responsibilities:

- LabVIEW Programmer for Clinical trials.

- Creation of eCRF's for Clinical trials.

- Accurate and timely data entry.

- Knowledge on ICH-GCP, HIPAA compliance.

- Prepared regulatory submissions.

- Created Case Report Forms and obtained Informed Consents from

subjects.

- Maintained patient databases, investigational logs, study

regulatory documents.

Graduate Research Assistant - October 2012- March 2013 (6 Months)

Supervised by Diane Kamen, MD.MSCR, Email: acf2f0@r.postjobfree.com, Division

of Rheumatology and Immunology, College of Medicine, Medical

University of South Carolina

Responsibilities:

- Data control and Quality check

- Developed REDCAP Projects

- Data Entry in EPIC,OACIS,REDCAP,PHAROS

INTERNSHIPS

College of Nursing, Medical University of South Carolina, January 2013 -

August 2013 (8 Months)

Mentor : Dr.Frank A.Treiber and Sachin Patel, MS

GRANT PROPOSAL: A Prospective Study to Compare Uterine Contractions

from EMG AND IUPC

A validation study to determine the accuracy between EMG and IUPC in

detecting the uterine contractions. Assessment of uterine activity is

essential in the progress of labor. Women in labor will be monitored

simultaneously with Electromyogram (EMG) and Tocodynamometry (TOCO)

for 20 minutes. Data will be collected and analysed in order to

detect the number of contractions.

Responsibilities :

- Assisted for Mobile Health Projects.

- Data Entry, Quality Control and Data Analysis and developed Redcap

Projects for LOVED and Duke Study.

Apollo Speciality Hospitals, Chennai

Responsibilities:

- Training in Quality Control, Quality Assurance and Packaging material

testing

- Testing efficiency of Biomedical Equipment.

- Maintaining Biomedical Records

PSG Institute of Medical Science & Research,Coimbatore

Responsibilities:

- Acquired knowledge about the Medical technologies and the prominent

usage of Biomedical Engineering applications in

therapeutics and diagnosis.

- Medical devices ranging from clinical equipment's to micro implants

and common imaging equipment's such as MRIs and ECGs and

pharmaceutical drugs.

ENGINEERING PROJECTS

Rider's Protection System

- I undertook an Embedded project which implements helmet-wear

compulsory for motor bike riders.

- An IR sensor is attached to the helmet to detect the blood flow

acting as transmitter and the receiver, which further ignites the

motor bike.

- The vehicle gets ignited only, if the blood flow is detected in the

helmet and transmitted.

Fingerprint Biometric Authentication System

- The objective of the project is to develop a cost-effective secured

key protection system using Fingerprint Biometrics Technology. The

aliveness and perspiration in the fingerprint is detected, and

matched with the existing database.

- If the scanned template matches the existing template, the tray

opens and provides the key.

SCIENTIFIC CONFERENCES AND PRESENTATIONS

- Participated in "One day workshop on recent trends in "Biomedical

Signal Processing and Instrumentation"2008, PSG College of Technology

- Participated in the colloquium on "BIOSENSORS '09", organized by the

Department of Biotechnology in PSG College of Technology

- Participated in bi-on 2009 "Workshop on Science and Technology in

Health Care", PSG College of Technology

- Participated in "XEROX '09", an intra-college pencil sketching

competition conducted by PSG College of Technology

- Participated in 2-day ROBOTICS WORKSHOP-BOTIX in simple labs, Chennai

- Attended "Pre-conference tutorials of the International Conference and

Exhibition on Biometric Technology"(ICEBT-2010) organized by the

Biomedical Engineering department, PSG College of Technology at the

residency, Coimbatore

- Participated in Biomed-2010 "National Level Technical Symposium"

organized by Biomedical Engineering Department, PSG College of

Technology.

- Participant in INTRAMS'11, PSG College of Technology.

- Participated in the "My Idea Programme "organized by Villgro,PSG

College of Technology,2011

PROFESSIONAL ASSOCIATION MEMBERSHIP

- Member of Indian Society for Technical Education (Students'

Chapter)for the academic year 2008-2009

- Member of 'WOMEN ENTREPRENEURS CONCLAVE '10 of entrepreneur week, PSG

College of Technology

- Member of STUDENTS UNION for the academic year 2007-2011, PSG College

of Technology

CO-CURRICULAR & EXTRACURRICULAR ACTIVITIES

- Secured Third in INTRAMS'08, Inter cultural dance competition at PSG

College of Technology, INDIA

- Organizer of the event "Magnum-opus" and "Big-Fight" in Bi-ON'10

conducted by BMEA, PSG College of Technology

- Organizer of Doctogineer at BI-ON-2011 conducted by Biomedical

engineering department, PSG College of Technology

- Organizer of Split Personality at BI-ON-2011 conducted by Biomedical

engineering department, PSG College of Technology

- Organizer of Paper Presentation in BI-ON-2011 conducted by Biomedical

engineering department, PSG College of Technology

- Volunteered in PSG TECH MINI MARATHON '08 held at COIMBATORE,INDIA

LEADERSHIP SKILLS

- Student chief-editor of BMEA NEWSLETTER'10 at PSG College of

Technology.

- President of Biomedical Engineering Association during the academic

year 2009-2011, PSG College of Technology

- Organized student activities and symposiums

- Started concept of "Big-fight", Debate Series in 2010

- Advanced organization and accounting skills while being the Member and

Chief Executive of students union and Kriya ( Technical Symposium) at

PSG College of Technology during the academic year 2007-2011

- Other interests include Photography, Dance, Singing, Volunteering.

- Languages: English(read, spoken, written),Hindi(read, written),

Tamil(read, spoken, written)

HOBBIES

Dancing, Designing and Coordinating.

REFERENCES

- Diane Kamen, MD,MSCR, Division of Rheumatology and Immunology, College

of Medicine, Medical University of South Carolina. Email:

acf2f0@r.postjobfree.com, Ph. 843-***-****

- Dr. Thomas C. Hulsey, Director, Division of Pediatric Epidemiology,

Medical University of South Carolina. Email: acf2f0@r.postjobfree.com, Ph.:

843-***-****

- Dr Reza Anari, Principal, ICRI Centre for Life Sciences and

Professional Management Pte Ltd Singapore. Email: reza@icriglobal-

research.com, Ph.: +65-97871583

Contact this candidate