Indira Jawahar

** ******* *****, ********, ** – *7094. Cell: 201-***-****, acegfn@r.postjobfree.com

Objective

Looking for an opportunity to work as a Clinical Trials Assistant, where I can improve my skills and knowledge in the field and gain

experience.

Summary

Master’s Degree in Zoology with a GPA of 3.75

Completed the professional certification program in Clinical Research Conduct and Management

Knowledge of ICH and GCP guidelines including the basic understanding of FDA regulatory requirements

Basic knowledge of clinical trial and drug development process

Education

2013 July to May 2014 – CERTIFICATE PROGRAM IN CLINICAL RESEARCH CONDUCT AND MANAGEMENT, UC BERKELEY

EXTENSION

Successful completion of course # 1

CLINICAL TRIAL PHASES AND DESIGN which included the following;

Drug discovery and development – Understanding the drug development process, Good Clinical practice – Historical perspectives and

principles of GCP, Regulation – FDA, ICH, Getting approval – IND Application, Clinical Trial Phases, Roles and Responsibilities – IRBs,

Sponsors, Investigators, Contract Research Organization CROs, Clinical Trial Design, Medical Devices – FDAs Regulation of Medical

Devices, Regulation of Medical Device Clinical Trials, Medical Terminology

Successful completion of Course # 2 –

CLINICAL TRIAL PLANNING 2013 Oct 24 to Dec 19

:

1. The role of data – Biostatistics, data management overview

2. Clinical trial protocol – Content, process

3. Data capture – Electronic records, CRFs

4. Data management – Data plan development, Database setup and validation

5. Informed consent – Elements, Investigator’s process of IC

6. Study start up activities – IRB submissions, selecting Investigators, staff and site

7. Site activities – Elements and tools for developing site budgets, Negotiating site contracts and budgets, Implications of the

elements of site contracts

8. Pre study Visits and SOP – The pre study visits, Pre study visit checklists, SOPs

Successful completion of Course # 3 – CLINICAL TRIAL IMPLEMENTATION: 2014 Jan 2 to Feb 27

Regulatory documents, Site initiation, Subject recruitment, Global development, Monitoring and Site Close out

Successful completion of the final course # 4 – DATA ANALYSIS AND PROJECT MANAGEMENT: MARCH 4, 2014 – April 27, 2014

Quality Assurance, audits and inspections, Project management, Vendor selection, Data analysis, Clinical study report, New drug

application.

1996 2001 MASTER OF SCIENCE IN ZOOLOGY, Madras Christian College, Chennai, India

Relevant coursework

Human Biology, Endocrinology, Biostatistics, Biophysics and Biotechnology

Academic Equivalency Evaluation Performed by World Education Services on 13 June 2011

The Degree M.sc in Zoology, Madras Christian College is equivalent of a Master of Science Degree from an accredited Us College or

University.

Skills

Knowledgeable about the regulations in Clinical Research, ICH – GCP guidelines, drug development

Proficient in the use of Microsoft Word, Excel.

Strong verbal and written communication skills

Excellent organizational and time management skills

Adaptable, self motivated, and detail oriented

Experience

Biology Teacher

ST. MARKS HIGHER SECONDARY SCHOOL, Chennai, INDIA

Nov 2001 – Aug 2003

Prepared and delivered lectures to students on topics such as morphology, anatomy, physiology, taxonomy and

nomenclature, cell biology, and reproduction. Evaluated and graded students' papers, assignments and class work.

Supervised laboratory examinations as an external examiner for other schools.

Prepared progress reports that included the scores and grades of each subject the student earned during each term.

Work Status

Green Card Authorized to work for any employer in the US

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