Clinical Research Associate

AVVARI KIRAN KUMAR

Contact : 201-***-****; Email: *************@*****.***,

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

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CLINICAL RESEARCH PROFESSIONAL

Strong track record of generating extraordinary performance in a fiercely

competitive scenario

Proactive decision maker, targeting challenging assignments as a Blood Bank

and clinical laboratory technician across functional sectors of Blood Bank

and clinical laboratory with reputed organizations and conducting clinical

trails according to ICH-GCP guidelines

PROFILE

. Confident to provide best patient care while handling simple as well as

complex procedures. Committed to make positive impact on patients,

colleagues, and staff.

. Acquired exposure to many complex procedures by assisting and observing,

track record of an outstanding performance with leading hospital. Devoted

& sincere professional, often complemented by patients for having steady

& fast hand.

. Good communication and interpersonal skills, multitasking with an ability

to interact with a wide range of people.

Core Competencies

. Blood Bank Operations ? Aphaeresis ? Regulatory Affairs ? Quality

Control/Assurance ? ISO/MIS/SOP ? Internal/External Audit ? Training &

Development ? Testing/Documentation ? Medical Care ? Project Management

? Empathy/Compassion ? Accreditation? Good knowledge in Clinical

Research and ICH-GCP guidelines ? Time management skills and ability to

meet challenges effectively ? Excellent written and verbal communication

skills ? Presentation skills ? Decision making, Problem solving and

analytical skills ? Committed to deadlines and work schedules ? Excellent

skills in Microsoft tools (MS Office) and internet skills ? Designing

Research proposals and posters ? Scientific writing skills through

portfolios.

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PROFESSIONAL EXPERIENCE

MAXNEEMAN INTERNATIONAL, DELHI May'10

to till 7July 2012

CRC (Monitoring phase II,III & IV)

. Perform site selection, initiation, monitoring and close-out visits in

accordance with contracted scope of work and good clinical practice.

. Provide monitoring visits and site management for a variety of

protocols, sites and therapeutic areas.

. Administer protocol and related study training to assigned sites and

establish regular lines of communication with sites to manage ongoing

project expectations and issues.

> Good knowledge in clinical trial process.

. Source Document Review.

. Entering the study data into eCRFs through databases like SAS CDMS

suite, PheedIt v3.03 based on the source notes.

. Site Investigator File Handling.

. IRB documentation

. ICF Process/Record.

. Patient Recruitment/Schedule Patient's visits/Patient Follow ups.

. Patient Counseling.

. Pre study visit, initiation visit, monitoring, study completion visit.

. Safety reporting

> Ensure that the study is in compliance with:

. Protocol.

. Site and Study specific SOPs.

. GCP.

> Basic Knowledge in:

. Clinical Data Management

a) Theoretical knowledge in designing paper CRF

b) Laboratory Reconciliation Process

c) Query Processing

d) SAE Reconciliation Process

e) Theoretical knowledge in edit check development

f) Database - PheedIt v3.03 for EDC

g) Basic training in Oracle Clinical.

h) Certification in SAS base program.

GOVERNMENT AREA HOSPITAL IN KOTHAGUDEM

Jan'06-Aug'08

(Under The Appointment of Lepra Society)

Blood Bank Technician

. Responsible for collecting blood bags, screening the blood samples by

ELISA method and SPOT methods.

. Responsible for cross matching the samples and issuing the blood bags to

the patients and maintaining the documents for collecting, issuing of

blood bags and issuing blood donor certificates to donors.

KRISHNA CLINICAL SERVICE CENTRE, KOTHAGUDEM

Aug'04-Aug'05

Lab Technician

. Experience of handling semi auto-analyser, microscopic

examination and collecting blood samples.

SKILLS:

- ms office

- Power point presentation

- Excel preparation

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STRENGTH

? Leadership skills ? Ability to work as part of a team ? Ability to work

under stressful conditions ? Good Communication Skills and other soft

skills ? Self Confident and self motivated person ? Quick Learner ?

Positive Attitude ? Determined ? High Energies ? Hard Working and Sincere

? Able to handle people in a very efficient way ? Event planning and

coordination ? Ability to learn quickly new software, reporting tolls and

associated process.

ACADEMIC CREDENTIAL:

< Master of Science, Clinical Research 2010 (Barnett GCP accreditation,

2010)

Institute of Clinical Research, India, Cranfield University, UK; 69%

Projects Undertaken

. Undertook a project on "Profile of the patients who are taking treatment

in DOT centre" in selected area of Andhra Pradesh- a questionnaire based

descriptive study during June - July 2009.

. Completed a project on "A Study on The Treatment Outcomes of Dots Therapy-

A Retrospective Approach" in selected area of Andhra Pradesh- a CRF

based study during May2010-Aug 2010.

Trainings Attended

. Attended 5 days training program "Induction programme for Laboratory

Technicians on HIV testing strategies" sponsored by APSACS from 4th Jan

to 8th Jan 2006 at IPM, Hyderabad.

. Attended 15 days training programme on Immuno Hematology at Central Blood

Bank, Hyderabad conducted by the AP State Aids Control Society from Aug

18th to 1st Sep in 2006.

(Reference on request)[pic]

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