CURRICULUM VITAE

S.KISHORE KUMAR

E-mail: k037c5@r.postjobfree.com Mobile: +91-998*******

k037c5@r.postjobfree.com

OBJECTIVE & PROFESSIONAL SUMMARY

A Clinical Research Professional with 3.8 years of experience in the field of clinical research, a combine resourcefulness and problem solving skills with clinical knowledge to consistently deliver improved ethical research and productive results. Good team player dedicated to quality with continuous improvement and bottom-line objectives.

EXPERIENCE SUMMARY

Working as a Drug Safety Associate-2 at Quintiles Technologies Pvt. Ltd., from April 2010 to till date

Worked as a CRA for Phase-II and Phase-III trials at Division of Clinical Research, St. John’s Research Institute, Bangalore, from September 2008 to April 2010.

Worked on “Quality of life in post Chikungunya fever arthritis patients treated with Sallaki: a Pilot Study”, (academic project) sponsored by Natural Remedies Pvt Ltd, Bangalore under the guidance of Dr. K. Venkateshwarulu, MD (Ayu), Medical Advisor- Ayurveda, from February 2008 to August 2008.

Key roles and responsibilities as a Drug Safety Associate:

Review, assess, triage, process and report the adverse event reports according to applicable regulations, guidelines, SOPs and project requirements with in the specified time lines by meeting the quality standards.

Ensure a duplicate check is conducted against the Global Safety Database in accordance with SOPs for all ICSRs (Individual Case Safety reports) in order to determine whether there is an existing case file.

Creating an electronic case report file for a new case.

Assessment of case reports for seriousness, case validation, causality and expectedness.

Prioritizing the adverse event reports processing base on the ICH dates.

Perform safety data entry in the database, coding relevant medical terminology, writing descript narratives, generating queries pertinent to the case, performing quality control and ensure case reporting.

Coding of medical history, drugs and reported adverse event terms in safety database using medical dictionaries like MedDRA, and WHO-DRL.

Filing PQCs (product quality complaints) associated with adverse events.

Performing quality review and checking cases for discrepancies for any errors related to labeling and narrative writing.

Setting up follow-up letter to the reporter for further case follow-up as per the applicable guidelines and reporting the case to the respective regulatory agencies.

Playing key role as an SME (Subject Matter Expert) and communicating with client on day to day basis regarding project related activities.

As mentor, training new team members on safety data processing and project related activities.

Attend project team meetings and client calls related to the project and provide feedback to operations manager on any challenges/issues or successes.

Perform other duties as assigned.

Key roles and responsibilities as a CRA:

Compilation of the study related documents during the pre trial Period and assist with IRB/EC submissions.

Ensure the conduct of the trials as per the ICH GCP & Protocol Specified guidelines.

Verifying the documentation of the informed consent Process for each study subject.

Ensure that non-serious and serious adverse experiences are properly documented and reported to the applicable regulatory authorities.

Reviewing the case report form (both paper CRF and electronic CRF) against the subject’s medical record and source for completeness and accuracy.

Performing study drug accountability.

Assisting study managers for start-up activities & site initiation.

Conduct Site Initiation Visits and ensure sites readiness.

Follow-up with sites for Recruitment & Retention.

Follow up with site team for timely completion of the Source Documents and ensuring that all the relevant information required in the Case Record Form are present in the source document.

Perform routine On-site monitoring visits as per the monitoring plan.

Perform Close-out visits.

Prepare monitoring visit reports

Maintenance of Trial Master Files

SKILLS SET

TECHNICAL SKILLS

Strong hold on safety data processing database.

MS Office, Hardware and software maintenance of all Microsoft based OS.

CLINICAL RESEARCH

ICH-GCP guidelines, Indian-GCP, Schedule Y, FDA and other relevant Regulatory Guidelines.

Protocol, Informed consent process, Case report forms.

Pharmacovigilance, Clinical data management.

Roles and responsibilities of various stake holders in clinical research, Clinical trials conduct, Research and Ethics governance, clinical trial logistics and supply chain management.

Done an online NIH training for, “Protecting human subjects” in clinical trails.

SOFT SKIILLS

Good interpersonal skills

Attention to detail and accuracy

Good communication skills

ACADEMIC PROFILE

Masters in Clinical research from Institute of Clinical Research (India) affiliated to Cranfield University, U.K, passed out in 2008

MSc in Microbiology from Sri Venkateswara University, Tirupathi, A.P, passed out in 2006 in first class with 68.54%.

Bachelor in Microbiology from S.S.B.N Degree College, Anantapur, A.P, passed out in 2003 with 63.72%.

Intermediate from Board of Intermediate Examinations, A.P, passed out in 2000 with 60.5%.

Secondary school education from L.B.E.M. School, Anantapur, A.P, passed out with 71.3% in 1998.

ACADEMIC PROJECTS

Done a project on “Quality of life in post Chikungunya fever arthritis patients treated with Sallaki: a Pilot study”. All documentation including Protocol, Informed Consent form, CRFs are done and ethical approval taken.

Done a project on Recombinant DNA technology.

PROFESSIONAL ACTIVITIES

Attended DIA conference at Mumbai in 2006.

Attended Clinical research in India, by ICRI in association with IISc and Govt of India.

Cleared ICH-GCP 2008 online exam conducted by PharmaXm, UK, with a score of 88%.

Attended a work shop on Pharmacovigilance, by ICRI in association with WHO, Geneva.

Attended a symposium on ICH-GCP guidelines, by ICRI.

REFERENCE

Tripti Ghosh

Associate Manager, Drug Safety Operation

Quintiles transnational Pvt. Ltd. Bangalore

Contact No: Available on request

Mrs. Preeti Girish

Senior Research Coordinator, Division of Clinical Trials

St. John’s Research Institute, St. John’s Medical College & Hospital, Bangalore,

Contact No: Available on request

Dr. Alben Sigamani

Project Manager, Division of Clinical Trials

St. John’s Research Institute, St. John’s Medical College & Hospital, Bangalore,

Contact No: Available on request

PERSONAL DETAILS

Permanent Address : # 13/2/13,

Uravakonda, PIN- 515812,

Anantapur, Andhra Pradesh,

Present Address : Jerita, No. 17/2, 1st main

1st Cross, Maruthi nagar,

Madiwala, Bangalore-560068

Date of Birth : 1st Jan 1982

Marital Status : Single

Languages Known : English, Telugu, Kannada and Hindi

Nationality : Indian

DECLARATION:

I hereby declare that the information furnished above is true to the best of my knowledge.

Yours Truly Place: Bangalore

Kishore Kumar. S

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