Mobile Phone: 009***********

E-mail: acuk3b@r.postjobfree.com

acuk3b@r.postjobfree.com

Rekha. V.

Career Objective

Sharp, analytical, and committed Pharmaceutical professional seeking for an opportunity, where there is scope for performance and leadership to achieve growth for self and organization.

Investigator Meeting

Attended the Investigator Meeting as an acting Principal Investigator which was held in Greece on 8th and 9th Nov 2012

Attended the Investigator Meeting which was held in Bangkok on 13th and 14th July 2013

Professional Training

ICH GCP,Schedule Y,OCRDC,SPSS

Projects

Formulation and Evaluation of Oral liquids

Isolation, Characterisation and Determination Of Marine sponge Clathria mima

Industrial training

BRIT, Vashi, New Mumbai (15 days)

Fourrts India Laboratory, Kelambakkam,Chennai (1 month)

Quintiles – Internship (1.5 month)

Industrial visits

GRANDIX PHARMA, Chennai

Dr. REDDYS Laboratory, Hyderabad.

Veeda clinical research, Ahmedabad.

Conferences

Participated in National Level Technical Symposium on “Pharma Innovation.”

Active member in International “E-Symposium”on Pharmaceutical

Engineering.

National Seminar on “Contract Research and Patent Rights”.

National Level Technical Symposium on “Exploring the Research Platform for P3D”.

Diana & Anderson – Patient Recruitment & Retention.

5th Annual surgical oncology workshop 2010, organized by Dept. of Surgical Oncology.

Attended World Lymphma Awareness Day – 28th Sep 2010.

Participated as a delegate in the “5th Annual short course in Clinical Research Methodology” held on 28th and 29th May 2011.

Attended World Lymphoma Awareness Day – 15th Sep 2011.

Attended Onco Surge Conference in 2011.

Attended 1st FERCI International Conference on Ethics Committee in 2011

Volunteered in 9th,10th and 11th conference on Evidence Based Management Of Cancers in India organised by CRS & DAE-CTC,Tata Memorial Hospital in 2011,2012 and 2013.

Technical Qualification

BTech – Pharmaceutical Engineering and Technology

APGDCR – Clinical Research and Management

Professional Experience

Tata Memorial Centre, INDIA

Designation : Clinical Trial Coordinator

Clinical Trial Experience:

Indication of study / Disease

Study type / phase

Role

Registry for Epidemiology and End result Analysis in adult and Pediatric Lymphomas (REEA-L)

Observational

Clinical Research Coordinator

Acute Myeloid Leukemia

Observational

Clinical Research Coordinator

Follicular Lymphoma

Phase III

Clinical Research Coordinator

Chronic Myeloid Leukemia

Phase III

Clinical Research Coordinator

Herpes Zoster (Vaccine)

Phase III

Clinical Research Coordinator

Responsibilities

Involved in assisting the PI for site feasibility and preparing the site for initiation activities.

Assisting PI in identifying potential patients for the trial and recruiting them.

Presenting the Informed Consent to the patients and documenting details of the process.

Completing Case Report Form (Paper and eCRF) within the stipulated timelines.

Data collection and management of all safety related events

Maintaining and updating of trial related documents.

Coordinating with ethics committee in submission of trial documents.

Preparation of Interim and Annual Reports of trials for sponsors as well as Ethics Committee of the institute.

Reporting SAEs to sponsors, Ethics Committee and DCGI as per the

defined timelines.

Maintaining communications with Sponsor

Capturing eCRF specific information from the source documents & updating the same in database

SDV, CRF completion & retrieval, DCF resolution.

Prompt and timely resolution of queries raised by sponsor.

Maintaining the statistics of the department assisting the PI in the preparation of Annual Report of the DMG.

IMP release, Inventory check & Accountability reconciliation

Training the assistant data managers on capturing the data for CRF.

Preparing invoices for the amount incurred during patient visits.

Preparing the site for close out and archival of trial documents.

Educational Details

Advance Post Graduation Diploma in Clinical Research, APGDCR

2008-2009

CREMA

76%

First class With distinction

Clinical Research Professional Developmental Program

2008-2009

Clinical Research International, Ontario, Canada

93%

First class With distinction

B.Tech Pharmaceutical Engineering &Technology

2004-2008

Bharathidasan Institute of Technology, Bharathidasan University

78%

First class With distinction(Hons)

Target Job

Job Category

Mid Level/Senior Level

Employment Status

Full Time

Current location

UAE

Notice period

Immediately Will Join

Computer Skills

Skill

Level

Auto Cad

Good

SPSS

Good

Word Processing – M.S. Word XP

Good

Spread Sheets - M.S. Excel XP

Good

Personal Information

Nationality

Date of Birth

Indian

05th January, 1987

Languages

Language

Level

English

Excellent

Hindi

Excellent

Marathi

Excellent

Tamil

Excellent

Malayalam

Good

Details of Passport

No.

N2130555

Date of Issue

03/08/2015

Date of Expiry

02/08/2025

Place of Issue

Mumbai

Rekha Vijayakumaran

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