Medical Coding

Dr. Chitra Raghunath

***** ***** **** ****** *** # 232

Scottsdale, AZ 85254

Home Phone: +1-623-***-****

Email: ********@*****.***

Objective

Looking for a challenging position as Drug Safety Specialist / Safety

Review Specialist Clinical Coding Specialist / Dictionary Coding

Specialist/ Clinical Data Coordinator in the field of clinical research

while merging into a globally focused organization that will purposefully

utilize my qualifications and offering several opportunities to integrate

personal enrichment with professional goals. Combine resourcefulness and

problem solving skills with clinical knowledge to consistently deliver

improved research and production result.

Professional Summary

Clinical research professional having a health care background with a

Degree in Dentistry & Post graduate Diploma in Clinical Data management

Worked as a Dictionary Specialist I at Theorem Clinical Research (Formerly

Omnicare Clinical Research) India (Apr 2009 to March 2011)

Worked as Junior Medical Writer at Ecron Acunova India (Oct 2007 to Mar

2009)

Worked as a dentist with three leading private clinic setups in India (Jul

2002 to Dec 2006)

Summary of Qualifications

. Strong knowledge of clinical trials and clinical data management

. Detailed knowledge of GCP and ICH guidelines including basic

understanding of regulatory requirements

. In-depth knowledge of medical terminology, data collection and clinical

research principles

. Experience with both paper based and electronic data capture based

clinical studies

. Excellent communication and project management skills

. Possess strong interpersonal and problem solving skills

. Self-motivated, and result-oriented

. Skilled in handling multiple projects simultaneously and ability to meet

tight deadlines

. Excellent team player and ability to perform tasks in a collaborative

working environment

Professional Experience

Theorem Clinical Research, Bangalore (India)

Dictionary Specialist I, April 2009 - March 2011

. Utilize medical and clinical knowledge to perform medical coding of:

. Adverse Events (AEs) and Medical History (MH) terminologies using

the dictionary Medical Dictionary for Regulatory Activities

(MedDRA)

. Concomitant Medications to the WHO-Drug Dictionary (WHO-DD) and

additionally also perform Anatomical Therapeutic Chemical (ATC)

Classification coding using WHO-Drug Dictionary (WHO-DD)

. Adverse event coding using Common Terminology Criteria for Adverse

Events (CTCAE) for Oncology Studies

. Produce high quality work using SOPs (Standard Operating Procedures),

guidelines and technical standards as defined by the organization

. Extensive and good working knowledge on Oracle Clinical, Oracle Thesaurus

Management System, Merge eClinical, MS Office - Word, Excel, PowerPoint

. Awareness of project timelines and complete coding tasks and clinical

data review per timelines

. Establish and maintain collaborative working relationships with study

sponsors

. Review client specific coding systems and guidelines. Prepare and perform

Medical Coding of Case report form (CRF) data (e.g. adverse events,

medication, medical history, surgical history) according to commercial

and/or study specific dictionaries. Assign codes to items requiring

coding. Review dictionary coding guidelines and provide inputs to the

data management plan

. Identify and review discrepancies and issue queries to resolve coding

related issues

. Generate medical coding reports for ongoing quality control review

. Review coding reports for completeness, accuracy, and consistency.

Identify coding changes and perform as necessary

. Generation of customized medical coding reports per the sponsor

requirement at the completion of clinical studies

. Provide coding support and assist Clinical data management (CDM) Managers

in daily coding operations. Respond to and solve coding oriented problems

in a timely manner, as appropriate for the position. Assist CDM Manager

with status reports and listings as necessary

. Provide dictionary training, assistance and support to in-house personnel

(Clinical Programming and Clinical Statistics team)

. Development of process documents and SOPs for the Dictionary Management

Team

. Experience and understanding of all tasks and responsibilities associated

with Clinical data coordinator/analyst

Ecron Acunova, Bangalore (India)

Junior Medical Writer, Oct 2007- March 2009

. Preparation and review of safety/SAE (Serious adverse events) narratives

. Preparation and review of protocols and clinical study reports for

Bioavailability and Bioequivalence Studies & Clinical Trials

. Preparation and review of CRF (Case Report Form) & ICF (Informed Consent

Form)

. Clinical Data Review including timely creation of queries and resolution

of issues related to the ongoing conduct and closeout of clinical trials

& Clinical Trial Quality Control

. Feasibility analysis for the clinical trial by discussing with Key

Opinion Leaders/Specialists in relevant area

. Working in close coordination with business development team in preparing

clinical trial proposals to national and international clients

. Preparation of Patient information leaflets - for clinical trial

participants/subjects

. Training clinical operations, statisticians & data management team on

basic medical sciences and study related medical training

. Provide appropriate clinical information to the statistical team for the

purpose of analysis

. Abstract writing

. Preparation of SOPs for the Medical Writing department

. Development of process documents for the Medical Writing department

Private Dental Clinics, Bangalore (India)

Dentist, July 2002 - December 2006

. Managed patients directly during the course of their treatments such as

Root Canal treatment, extraction, restorations, Pediatric dental

interventions, Orthodontic Treatment

Academic (Education) Profile

Degree Institution Year of Percentage

passing

Post Graduate Institute of Clinical Research 2007 90%

Diploma in (India), Bangalore

Clinical Data Karnataka

Management

Bachelor of Dayananda Sagar College Of Dental 2002 64%

Dental Surgery Sciences, Bangalore

Karnataka

Professional Project Experience

Project Experience

Project Description Role &

Responsibilities

Client Therapeutic Area Project

Details

Swiss Gastroenterology (Active Phase Ia/II, Medical Coding

Multinational Crohn's Disease) Multicentric

Company

US Multinational Oncology (Advanced or 5 different Medical Coding,

Company Metastatic Cancer) Phase I, Clinical Data Review

Multicentric

US Multinational Hematology Phase I Medical Coding

Company

Asia Pacific Gastroenterology Phase II Medical Coding

Multinational (Diarrhoea)

Company

UK Multinational Ophthalmology Phase IV, Medical Coding

Company (Blepharospasm) Multicentric

UK Multinational Musculoskeletal Phase IV, Medical Coding

Company (Cervical Dystonia) Multicentric

Indian National Respiratory (Asthma) Phase II Medical Coding

Company

Indian National Respiratory (Asthma) Phase II Medical Coding

Company

Indian National Allergic Disorders Phase III, Medical Coding

Company (Allergic rhinitis) Multicentric

US Multinational Women's Health (Breast Observational Medical Coding

Company Cancer) study

US Multinational Cardiology/Vascular Phase II, Medical Coding

Company (Hyperlipidemia) Multicentric

Indian National Oncology Phase II, Medical Coding

Company (Oral Leukoplakia ) Multicentric

US Multinational Ophthalmology (Ocular Phase IIb, Medical coding

Company Device Implantation) Multicentric

Indian National Respiratory (COPD) Phase IV Medical Coding &

Company Protocol Briefing to

the Statistics and

Clinical Data

Management teams

US Multinational Ophthalmology Phase III Medical Coding &

Company (Anti-Inflammatory Protocol Briefing to

Agent) the Statistics and

Clinical Data

Management teams

Indian National Oncology Phase II, Medical Coding &

Company (Cervical Cancer) Multicentric Protocol Briefing to

the Statistics and

Clinical Data

Management teams

West Asian Central Nervous System Phase IIIb, Medical Coding,

Multinational (Multiple Sclerosis) Multicentric Clinical Data Review

Company & Safety Narratives

West Asian Central Nervous System Phase IIa, Medical Coding,

Multinational (Multiple Sclerosis) Multicentric Clinical Data Review

Company & Safety Narratives

Indian National Gastroenterology Pharmacokinet Preparation and

Company ic studies review of Protocol,

Informed Consent

form (ICF) and

Safety Narratives

Indian National Gastroenterology Pharmacokinet Preparation and

Company ic studies review of Protocol &

ICF preparation

Indian National Dermatology Pharmacokinet Preparation and

Company ic studies review of Protocol,

ICF & Clinical Study

Report (CSR)

including Safety

Narratives

European Cardiology (Diuretics) & Pharmacokinet Medical Coding,

Multinational Urological Disorders ic studies Preparation and

Company review of Clinical

Study report

including Safety

Narratives

Indian National Cardiology Pharmacokinet Preparation and

Company (Hypertension) ic studies review of Clinical

Study report

including Safety

Narratives

Indian National Cardiology Pharmacokinet Preparation and

Company (Hypertension) ic studies review of Clinical

Study report

including Safety

Narratives

US Multinational Central Nervous System Pharmacokinet Preparation and

Company (Bipolar Disorders) ic studies review of CSR

including Safety

narratives

Indian National Cardiology Pharmacokinet Preparation and

Company ic studies review of Clinical

Study report

US Multinational Oncology (Prostate Pharmacokinet Medical review and

Company Cancer) ic studies inputs during

designing of Case

Report Forms

Courses, Workshops & Seminars Attended

Attended MedDRA Coding Basics and Introduction to MedDRA Data Analysis and

SMQs for Physicians Webinar

Attended a 2 days training session on "Pharmacovigilance", organized by

ICRI on 12-13th April 2007 at IISC, Bangalore

Attended a 1 day conference on "Analysis and Reporting of Adverse Events"

organized by Indian Association for Statistics in Clinical Trials on 9th

July 2010 at Hotel Lalit Ashok, Bangalore

Cleared Basic GCP knowledge according to Ecron Acunova SOPs

SWIFT Course in Basic Computer Application from NIIT, Bangalore

Personal Details

Date of Birth 16 - 11 - 1979

Languages Known English, Hindi, Kannada,

Tamil

Nationality Indian

H1b Visa Sponsorship Required

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