My Profile

Address: S.No.**/*, Road No. *

Matenagar, Wadgaonsheri

Near Niramay Hospital

PUNE - 411014

Mobile: 098******** /996*******

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

NAME: SUSHMA PADMANABHAN NAIDU

Objective:

 Seeking a suitable job in the pasture of Clinical Research and Clinical Data Management

Academics:

Degree Board/University Subjects Year of Passing Division

Post-Graduate Certificate Course in Clinical Research and Clinical Data Management Pune University Clinical Research and Clinical Data Management 2008 Distinction

M.Sc. Kakatiya University, A.P. Environmental Science 1999 First

B.Sc. Osmania University,

A.P. Microbiology 1996 First

H.S.C. Andhra Pradesh Physics, Chemistry, Biology 1993 First

S.S.C Andhra Pradesh Maths, Science, English e.t.c. 1991 Distinction

Academic highlights:

1. Attended the workshop of Quality Control in clinical trails conducted Pune University

2. Attended the Investigator’s meeting of Phase II, III trails in Bombay (ICH-GCP guidelines, Schedule Y, protocol discussion, CRF etc.) from Ruby Hall Clinic

3. Attended the ICH-GCP, Schedule Y training program conducted by Sanofi Aventis in Pune on 2nd January 2006

Research Projects Envisaged:

1. Phase II, III and IV clinical trials

2. Proposals to sponsors for conducting Clinical Trials through CRO

Technical Skills :

 Certificate in Computing,

IGNOU, Delhi.

 Typing speed – 60 words/min

 Proficient in MS-Project and worked with the same for Phase II, Phase III drug trial projects

Work experience:

TOTAL WORK EXPERIENCE ( RECENT TO PREVIOUS ) :

Currently working for Quantum Ltd (Clinical Research Organization) as an Assistant Manager of Clinical Operations from Jan 2007 to till date

Responsibilities

 Knowing the protocol

 Communicating with all the parties who involved in administering the study

 Organizing and preparing for the EC meetings, solving queries and doubts raised by IRB (institutional Review Board) members

 Making sure that CRO has everything for central IRB submission

 Investigational Medicinal Product (IMP) management

 ENROLL SUBJECTS

 Performing study assessment, Initiation, monitoring and close out visits of all the clinical trials conducting in various sites

 Deciding budgets, milestones, summaries of the projects

 Planning, scheduling and executing the projects to the requirements of the clients

 Making monitoring plans and coordinating to ensure timely monitoring of the sites for GCP and SOP compliance with CRAs

 Training and guiding the Clinical Research Associates (CRAs) appointed for the administration of the clinical trials at the sites and auditing the same for the perfection

 Gathering the information regarding regulatory authorities

 Reviewing the FDA/ICH/GCP guidelines and participating in the investigator’s meeting and conducting awareness program of the same for our team members

 Reporting to my Seniors - related to studies, their progress and progress of the team

 Preparing Study Plans, Project out lines related to duration of the study

 Quality checking of the data generated by CRAs

 Taking responsible for the management of all sites conducting trials and all CRAs progress.

 Well conversant with the other aspects of clinical trial like –

 Regulatory affairs, Site Management etc

Previously Worked in Ruby Hall Clinic (Multispecialty 550 bedded Hospital) , Pune for 4 years from January 2003 to December 2006 as a Clinical Research Coordinator or Study Coordinator

Responsibilities Included

 Providing the feasibility information of PIs to pharmaceutical companies or CROs for the clinical trials

 Knowing the protocol

 Organizing the EC (Ethics Committee) meetings and fulfilling their requirements for the study to be initiated and getting the approvals of the trial studies

 Screening the patients for drug trials of reputed organizations

 Taking responsibility of enrolled patients by PI (Principal Investigator) and making sure that the Principal Investigator is conducting the study according to the protocol of the study

 Taking and counseling for informed consent documents from the subjects before the study

 Filling paper and eCRFs

 Reporting AEs (Adverse Events) and SAEs (Serious Adverse Events) to the regulatory authorities and resolving queries of the same

 Responsibility of drug storage, blood samples(plasma and serum), other biological (urine, faeces, CSF, Biopsy samples etc) and transporting them to the related laboratory

 Well versed with IVRS (Interactive voice recognition system) operations and experience of online enrolling, randomizing etc of the subjects

 Attending the investigator meetings

 Filing all the trial-related documents regarding study start up and IRB correspondence

 Maintaining Investigator Site Files with all the relevant documents

 Quality checking of the data made by doctors/hospitals during screening and keeping record of copy of Source Documents from the hospital file etc, organizing studies with full proof work plan and getting it executed

 Supporting external QA audits

 Complete follow up with the PI, other CRAs, QA, Ethical committee and regulatory affairs personnel

 Destruction of the study bio medical waste according to the guidelines of the Bio Medical waste treatment available at the site with the help of concerned department professionals and providing them the certificate

 Archival of the study documents according to GCP guidelines and regulatory authorities

Personal Information:

Birth Date : 03/October/1975

Sex/Marital status : Female/Married

Proficiency in Languages : English, Telugu, Hindi, Marathi

Place: PUNE

Date: 3/June//2008 NAME

SUSHMA PADMANABHAN NAIDU

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