documentaiton co ordinator

SASIKUMAR NATARAJ

*/**. ********* **** **, Neelangarai, Chennai – 600 041, Tamil Nadu

: +91-996*******; Email: sasikumarnataraj@gmail.com________________________________________

CLINICAL RESEARCH & QA PROFESSIONAL

Seeking a challenging assignment in an eminent organization, where I can get the opportunity to hone my competencies and utilize my potential to contribute towards the organizational goals

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PROFILE

Diligent & competent professional with rich experience of 3+ Years in the realm of Clinical Research. Possess knowledge of Clinical Research, Quality Assurance & Regulatory authorities.

Demonstrated skills in developing new formulations, conducting research survey and formulating trials on various approaches. Dexterous in conducting the facility audit in the Clinical section for checking the adherence of SOP and other regulatory compliance in the initiation and reporting phase of the bioequivalence studies.

Sound knowledge of the broad aspects of fundamentals of clinical research involving conduct, design and management of clinical trials in accordance with GCP / GLP regulations along with the Indian regulatory structure. Adept in Lab - Ethics Committee Permission Process, Clinical trial, Initiation, Monitoring, Close out, Data Analysis, Archiving. Well versed in Legal aspects of clinical research & Scheduled Y of Drug and Cosmetic Act 1940

Superior diagnostics skills, expertise in identifying issues, forming hypothesis, designing and conducting analysis, synthesizing conclusions into recommendations and implementing change. Ability to establish priorities and to plan, coordinate and monitor own work plan and the team.

An effective team player, mentor with exceptional planning and execution skills coupled with a systematic approach and quick adaptability

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PROFESSIONAL CHRONICLE

ROXAANE RESEARCH LIMITED, Chennai since Feb 08

Quality Assurance Officer

Responsible for Clinical Research studies and ensuring that they are conducted in accordance with the protocol, standard operating procedures, good clinical practice as well as applicable regulatory requirements

Accountable for conducting the facility audit in the Clinical section for checking the adherence of SOP and other regulatory compliance in the initiation and reporting phase of the bioequivalence studies.

Instrumental in reviewing Clinical raw data for internal consistency, reviewing of draft protocols, amendments, sample case report forms, and sample Informed Consent Forms & providing inputs before finalization of the same.

Initiate clinical trial according to the relevant standard operating procedures (SOP & to ensure compliance with the protocol and regulatory and ICH GCP obligations

Actively involves in the Investigators meeting and entrusted with the task of imparting training to the newly appointed/permanent staff of the CRO

To maintain the training records of the personnel and co-ordinate the training program within the facility.

To co-ordinate with QA staff personnel in preparing the facility for inspections and external Audits.

Maintenance of Master Copy of SOP’s and distribution of controlled copies, Maintenance of Inventory Log Books, raw data forms& also to check the availability of raw data forms& log books; onus of carrying out Source Documents Verification in accordance with protocol, SOP and ICH-GCP guideline and also reviewing completeness and accuracy of trial records and Investigators site file

Developing uniform format for each document type, including standardized format for forms.

Manages processes for noncompliance corrective action plans.

Deftly carrying out other responsibilities such as Periodic review, distribution, maintenance, withdrawal and archiving of SOPs.

To ensure an adequate and safe working environment within CRO.

Library Section

Spearheading efforts across as In charge of Library Section

Marinating records, journals, test report, annual report, trail agreement, etc

Accountable for Labeling records for easy display and identification

Create and maintain appropriate documentation as per medical and regulatory requirements

Instrumental in maintaining & updating files and records on daily basis.

Meet Universal regulatory acceptance

HUCLIN RESEARCH LIMITED, Chennai March 2007 to Feb 2008

Quality Assurance Executive

BLUE MOUNTAIN SPRINGS (P) LTD, Kotagiri June 2002 to feb2007

Chemist

MERIT INERNATIONAL INSTITUTE OF TECHNOLOGY., Ooty July 2001 to May2002

Faculty

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EDUCATIONAL & PROFESSIONAL DEVELOPMENT

M. Sc. (Biochemistry) 1997-1999

Bharathidasan University Trichirapalli, TamilNadu

B.L.I.S 2010

Madurai Kamaraj University, Madurai

Computer Skills

Operating Systems UNIX, Windows.

Office Tools MS Office 2000, Power point

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ACADEMIC PROJECT

Prospective observational study of “Infection in Pregnant woman of Namakkal District organized from Dept of Experimental Medicine Dr. M. G. R. Medical University, Chennai.

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TRAINING PROGRAMS

Certification of Cold Chain Management Awareness Course and Dangerous Good Awareness with Concentration on Preparing Handling AVD Transporting Infectious Substances by air from World Courier Private limited

Participated CAP Laboratory Accreditation Program organization by Chetinad Health City hospital at Chennai on 2 May 2008

Participated Leptospira Diagnosis training program organization by Dept of Experimental Medicine of the Tamil Nadu Dr. M. G. R. Medical University, Chennai on13th and 14thMarch 1999

Worked in NSS team, (Bharathiyar University –Coimbatore).

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Date of Birth: 16.10.1975

Linguistic Proficiency: English & Tamil

References: Available on Request

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