Data Entry Quality Assurance
Resume:
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: *********@*****.***,
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: ********@*****.***
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:
******@****.***, 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: ******@****.***, 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:
******@****.***, Ph. 843-***-****
- Dr. Thomas C. Hulsey, Director, Division of Pediatric Epidemiology,
Medical University of South Carolina. Email: ********@****.***, Ph.:
- Dr Reza Anari, Principal, ICRI Centre for Life Sciences and
Professional Management Pte Ltd Singapore. Email: reza@icriglobal-
research.com, Ph.: +65-97871583
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