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