SMITHA. V

C K Venkatesh

Contact No.: 996-***-**** #19, I Main, SREERANGAM

E-mail: qztvni@r.postjobfree.com Canara Bank Colony

Bangalore-560072

Karnataka, India

CAREER GOAL:

To work in a challenging, result oriented position, where my skills of working successfully under any kind of circumstances in a team or independently, will make significant contribution to my organization's success in the field of Clinical Research.

Domain and Technical skills

• Protocol design

• Experienced in e-Crf , IWRS & IVRS by Perceptive.

• Understanding CDM (Clinical data management system)

• Consolidating the data from different legacy system collected from various sites

• Review testing results and generating reports on the results by using BI tools (INFORMA, MEDIDATA RAVE, ORACLE)

• Electronic Data Capture

• Supporting to Trial Data Center and resolving the queries

• Preparing training presentation and also weekly/monthly progress charts by using MS PowerPoint

• Developing reports and sending to respected sites based requirement in the form of MS excel/pdf/ PowerPoint

• Assist in trouble shooting as necessary.

TOOLS EXPERTISE: Proficiency in MS office (MS word, excel and power point)

• Application /Tools: Oracle Clinical, InForm, and Medidata Rave

• Basic knowledge of SQL.

Knowledge about SAS:

• Creating list reports

• Programming with data steps

• Creating & applying User defined

• Creating SAS data set

• SAS SQL

• SAS MACRO

PROFESSIONAL EXPERIENCE

Total experience in CLINICAL RESEARCH is 3.4 Years

Currently I am working as a In-house Clinical Research Associate in Arianne Clinical Research Pvt. Ltd. CRO Bangalore.

Nature of job:

• Administrator/Manager of Clinical document control room.

• Manage document tracking system.

• Ensure document compliance with Good Clinical Practices (GCP).

• Review and process clinical documents for submission to central files.

• Assist with site status reports.

• Assist with the development of administrative systems and procedures for document

management.

• Assist regulatory and drug safety group.

• Communicate with sites, clinical vendors, and others within the company, both in and

outside the department.

• Review and resolve discrepancies in clinical data at clinical sites and central laboratories

via query process.

• Adhere to company SOPs, FDA regulations and ICH guidelines.

• Track clinical data, regulatory documents, patient enrollment, and data resolutions to

assure the timely completion of clinical studies.

.

CLINICAL RESEARCH ASSOCIATE

Frontier Lifeline Pvt. Ltd (Oct 2007 - Mar 2010)

Company : Frontier Lifeline Pvt. Ltd – Chennai

Department : Clinical Research

Company Profile : The International Centre for Cardiothoracic and Vascular Diseases started by Frontier Lifeline is brainchild of the prodigious Dr. K. M. Cherian. Gifted with compassion, passion, humanitarianism and an awesome sense of dedication, Padmashree Dr. K. M. Cherian leads a skilled and carefully orchestrated team to empower and resuscitate the core of life. Aided by the most advanced technology, the strength of the centre lies in its team of highly dedicated, experienced and competent doctors, paramedical staff whose perennial motto is “Service before self”.

ROLES & RESPONSIBLITIES:

AS A MONITOR:-

Site Selection & identification of potential investigators

o With qualified, experience, trained & educated investigator in well authenticated hospital.

Study initiation

o With completeness of study specific training, GCP training & regulatory documents such as ethics Committee submission and other regulatory requirements.

Study Monitoring

o On-Site & In-house

o By assuring completeness ICD, CRF, Drug accountability & trial under Regulation of GCP & GLP.

o Reporting of study progress at regular intervals, Serious adverse event reporting.

Study Close-out

o With comprehensive overview of study relevant documents retrieval of CRFs, drug accountability & destruction resolving Budget & other miscellaneous issue Submission of clinical study reports to the regulatory authority , ICF & regulatory documents with final study report to the regulatory authority ethics committee.

MANAGEMENT & TECHNICAL ACTIVITIES

To arrange Investigator Meetings, provide administrative support for Investigator Meetings, overseeing presentations and scheduling activities, as and when required.

Perform & submit the feasibility report to the clinical trial department within appropriate timelines.

Feasibility questionnaire preparing Draft Clinical study report writing, assisting in Medical writing, & scientific and safety consulting,

Preparing presentation for site initiation (protocol training, GCP training, safety issue & monitoring plan etc

Experienced in e-Crf , IWRS & IVRS by Perceptive.

Arranging drug supplies & CTM for all the sites

Involving preparation of financial aspects of any clinical trial.

Negotiated the budget and finalized the contract with the investigators.

Interacting with PI of all the sites to take study status.

REGULATORY ACTIVITIES

Compilation of Dossier, IND files & interacting with Ethics Committee if require.

Compelling the documents for CDL approval.

TRIAL MONITORED

PHASE- III TRIAL

1. A Randomized, comparative, double blind, multi-centre, phase III clinical trial to evaluate the efficacy and safety of anticoagulant therapy for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation.

2. A Randomized, double blind, parallel group, phase III clinical study to determine the efficacy and safety of AZD6140 compared with antiplatelet drug for prevention of vascular events in patients with non ST or ST elevation acute coronary syndromes (ACS).

3. A randomized, double blind, placebo controlled international phase III study for cardiovascular medicine for the management of severe chronic heart failure.

Education Qualification

PG Diploma in Clinical Research(2005-2007)

ICRI, Bangalore affiliated to Cranfield University (U K)

B.Sc (Microbiology, Biochemistry and Botany)

Chitradurga Science College from Kuvempu University (2002-2005)

Plus Two (Physics, Chemistry, Mathematics and Biology)

Sri Vidya Peeta College from Pre University Board (2000-2002)

Project done during course:

Project Name: “Quality of Life Study in Patients with Moderate Hypertension”

Objective: Primary objective was to assess Quality of Life (QoL) parameters in patients with moderate hypertension who are on antihypertensive therapy.

Secondary objective was to standardize the questionnaire used in the study.

Duration : 2 Months

Place : Mallige Medical Centre, Bangalore

Investigator : Dr. T S Ravindra

The study involved 50 patients with moderate hypertension (which was controlled) on different antihypertensive regimen aged above 18 years. This is a questionnaire (QoL questionnaire) based study.

End Point: Score of functionality at different levels mentioned in the questionnaire.

PERSONAL DETAILS

DOB : 03-04-1985

Age : 24 years.

Sex : Female

Marital status : Unmarried

Nationality : India

Father’s name : Mr. Venkatesh C K

Languages known : English, Kannada, Hindi, Telugu, Tamil

Passport No. :G2027830

Issue Date :12/03/2007

Expire Date :11/03/2017

Place of Issued : Bangalore

Hobbies : Collecting stamps of various countries, Gardening,

Internet browsing, listening to music and watching movies.

Strengths:

Good knowledge of Clinical Practice

Ability to work in a team.

Quick learner with good grasping ability.

Willingness to work hard with dedication.

Ability to meet deadlines and handle multiple tasks.

Positive thinker.

Friendly in nature.

Achievements

Workshop and training attended:

1. Actively participated in a Workshop on “Biostatistics in Clinical Medicine, Public Health and Research” at Institute of Clinical Research(India), Bangalore from 29th – 31st May, 2006

2. Also participated in a workshop on GCP conducted by Quintiles at Chennai (Sep 2008)

3. Electronic Data Capture for site coordinator training from Medidata University.

4. Audit Approach and Key GCP Principles - Version 2 - Generic online Training from Sanofi Aventis

Business Traveled to Kuala Lumpur - Malaysia (March 2008): Attended global meeting about project the RE-LY (Randomized Evaluation of Long term anticoagulant therapy) comparing the efficacy and safety of two blinded doses of dabigatran etexilate with open label warfarin for the prevention of stroke and systemic embolism in patients with non-valvular a trial fibrillation: prospective, multi-centre, parallel-group, non-inferiority trial conducted by Boehringer Ingelheim Pharma - Malaysia

Conferences attended: Hyderabad –India – May-2008 attended training project SHIFT: Effects of ivabradine on cardiovascular events in patients with moderate to severe chronic heart failure and left ventricular systolic dysfunction and it is a three year randomized double blind placebo- controlled international phase III study Conducted by the George Institute for International Health

Other Activities:

I was a NSS candidate during college (B.Sc) days. In those days I participated in “Preventive Conservation of monument, cultural awareness youth camp.”

Participated in various activities like sports, quiz and participated in drawing competition.

Declaration:

I hereby declare that the above given information is true to the best of my knowledge and belief.

Place:

Date Smitha V

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