Clinical Research Coordinator, Data Management, Pharmacovigilance

JINO JOY

Mob: +91-996*******

*******@*****.***

Objective:

Seeking a position to utilize my skills, abilities in the field of clinical research that offers career, security and professional growth and also to establish myself as an asset to the organization. Experience:

Organisation : Tata Memorial Centre - Advanced Centre for Treatment, Research and Education in Cancer (TMC-ACTREC)

Designation : Clinical Trial Coordinator in Surgical Oncology Department. Projects:

1. Role of 3-D Navigable Ultrasound in resection of intra-axial brain tumors - A Randomized controlled study.

2. Understanding the mechanisms of ALA-induced fluorescence in malignant gliomas

– Exploring the biological basis of tumoral heterogeneity. 3. Comprehensive Analysis Of Different Grades Of Human Meningiomas; A Proteomics Approach To Decipher Disease Pathobiology And Identify Surrogate Protein Markers

Period worked : From February 24, 2014 to till date Job profile : Screening and enrolling subjects in studies and managing their participation according to ethical, regulatory, Institution SOP and protocol-specific requirements. Documenting and assuring that the Consent process has been done 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. Communicating with the IEC/IRB as appropriate.

Reporting Serious Adverse Events to the concerned regulatory authorities. Participating in audit preparation activities.

Accurate and timely data entry.

Organisation : ICON Clinical Research Pvt Ltd

Designation : Asst Clinical Data Associate in Clinical Data Management Department. Period worked : From June 06, 2011 to September 21, 2012 Job profile : Accurately review Case Report Form data for completeness, accuracy and consistency in accordance with all applicable procedures; Identify and appropriately address data discrepancies in the clinical data via computerized edit and manual text/listings;

Accurately generate data queries to resolve data discrepancies; Appropriately address responses to data queries and accurately update the Clinical data as necessary;

Accurately and consistently apply data handling convention to Case Report Form as necessary in accordance will applicable procedures; Perform quality reviews and appropriately identify all issues; Compile and distribute necessary study documentation and maintain accurate and complete study file in accordance will applicable procedures. Organisation : Cognizant Technology Solutions

Designation : Junior Clinical Data Analyst in Pharmacovigilance Department. Period worked : From Feb 22, 2010 to Dec 09, 2010

Job profile : Narrative writing, case processing as recommended by USFDA in compliance with 21CFR11 as per Good Pharmacovigilance Practices.

Receive, handle and accurately document Adverse Event, Product Complaint and Medical Inquiry calls as per the Standard Operating procedure. Answering any Medical Inquiries regarding the drugs. Accurately identify & capture any Adverse Event related to the drugs. Document any product related complaints for the drugs. Providing information regarding Pfizer Drugs to Health Care Professionals. Organisation : Cipla Ltd

Designation : Management Trainee

Period worked : From March 25, 2008 to September 15, 2008 Job profile : Marketing & Organizing meetings

Industrial Training

Underwent Industrial Training as part of my education at

Labindus Ltd, Palakkad (dealing with manufacturing of syrups, tablets & suspensions) during the period May 16 to May 31, 2006 for 100hrs in Quality Control Department.

Gujarat Inject (Kerala) Ltd, Palakkad (dealing with manufacturing of intravenous fluid) during September 2006 to May 2007 for 300hrs. My trust area of training was the Manufacturing and Quality Control Dept, where I went through various methods and procedures of analysis and also did hands-on analysis. Academics:

Qualification Name of Institution/University

% of marks

obtained

Year of Completion

PG Diploma in

Clinical Research

Institute of Clinical Research (India),

Mumbai

69% Dec 2009

B Pharm

Grace College of Pharmacy,

University of Calicut, Kerala

75.7% I Year, Oct 2004

71.4% II year, Nov 2005

73.7% III Year, Jan 2007

74.1% IV Year, Jan 2008

Plus Two

B E M Higher Secondary School,

Palakkad, Kerala

67.0% March 2003

S S L C

Kanikkamatha English Medium School,

Palakkad, Kerala

78.5% March 2001

Additional qualification:

Qualification Name of Institution Year of Completion Certificate Course in

Laboratory Animal Science

Advanced Centre for Treatment, Research and

Education in Cancer (ACTREC), Kharghar and

National Institute of Animal Welfare (NIAW)

February 2013

Short Course in Clinical

Research Methodology

Tata Memorial Centre, Mumbai August 2010

Computerised Pharmacy

Practice

Kerala State Pharmacy Council March 2006

Strengths:

Good communication skill

Ability to work under pressure

Time management

Adaptability with the environment

Achievements:

State level winner and National level participant of Indian Pharmaceutical Association’s National Elocution Competition, 2007.

Participated in All India Essay writing competition conducted by Sree Ramchandra Mission’s Sahaj Marg Research and Training Institute, Chennai held in the year 2001. Conferences attended:

2nd Global Cancer Genomics Consortium – Tata Memorial Centre Symposium during 19th – 20th November, 2012

Conference on "Science and Technology: Ethical Issues" conducted by Indian Women Scientists' Association, Navi Mumbai during 28-30 January, 2011.

Seminar on “Advances in Pharmaceutical Sciences” on 23rd November, 2007 at Sri Ramakrishna College of Pharmacy, Coimbatore organized by Indian Pharmaceutical Association (Education division) Mumbai.

Personal Details:

Present Address : 602, Green Heights

Plot No.22, Sector-35E, Kharghar

Navi Mumbai-410 210

Permanent Address : Joy Bhavan,

Vill/PO- Kalliyoor

Trivandrum, Kerala-695 042

Date of Birth : 02nd July 1985

Nationality : Indian

Sex : Female

Marital Status : Married

Languages known : English, Hindi & Malayalam

Reference:

Dr. Aliasgar V Moiyadi

Prof & Consultant Neurosurgeon,

Officer-In-Charge, Surgical Oncology

Advanced Centre for Treatment Research & Education in Cancer (ACTREC) Tata Memorial Centre

Kharghar, Navi Mumbai-410 210

Tel: +91-22-274*****; Mob. +91-932*******

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

Dr. Arvind Ingle

Officer In charge, Laboratory Animal Facility

TMC/ACTREC

Kharghar, Navi Mumbai-410 210

Tel. +91-22-274*****; Mob. +91-996*******

e-mail: ******@******.***.**

Date : 25.06.2015

Place : Navi Mumbai

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