Curriculum Vitae s506

CURRICULUM VITAE

K.N.V. RAJESH

LIG - 409, 1st phase, Road No-3, KPHB Colony, Hyderabad – 500072. Mobile: +91-9948123568 E-Mail: [email protected]

CAREER OBJECTIVE To work and grow professionally and mutually benefit myself and the field of clinical research.

WORK EXPERIENCE . 2 years and 9 months Experience in the field of clinical research (It includes Pivotal /Pilot BA/BE studies, Food Effect Studies, Multiple dose studies, Urine studies, Open label Single blinded studies and double blinded studies etc). . Working as a “Clinical Research Associate -III” in Axis Clinicals Ltd (Formerly Trident Life Sciences ltd) from July 2009 to till date. . Working as a “Study Custodian” & “Quality Control Personnel” Conducting Bio-Availability/Bio- Equivalence Studies.

. “Registered Pharmacist” in Pharmacy Council of India, from 2006 to till this time.

ACADEMIC QUALIFICATION

Year of Course Board/University Percentage passing Bachelor in Pharmacy Acharya Nagarjuna University 2009 75% Diploma in Pharmacy State Board of Technical Education & Training A.P 2006 78% Intermediate M.P.C Board of Intermediate A.P 2004 81% S.S.C Board of Secondary Education A.P 2002 65%

SPECIALIZED SKILLS  ICH-GCP Guidelines  Knowledge of IRB & IEC  Knowledge about protocol, CRF, ICF, IB  Knowledge about BA/BE Trails  MS Office, Excel, Power point, Internet Applications. Clinical Research Audits faced:  Study specific audits & Facility audits by different Sponsors & Regulatories. CURRICULUM VITAE  US FDA, UK MHRA, ANVISA, TGA, IRB & IEC, DCGI.

JOB PROFILE

As a CLINICAL RESEARCH ASSOCIATE-III Personnel

 Hands on experience working with more than 360 BA/BE studies.  Study Custodian, which includes Planning and presentation of clinical research study information, Obtaining Informed Consent, Supervision of study related activities and Clinical data review (Compliance with Protocol, GCP).  Execute the studies as per protocol, SOPs, GCP and other regulatory requirements.  Presentation of Informed Consent form to the volunteers / study subjects.  Verifying the documentation of the Informed Consent form for each study subject.  Monitoring & performing dosing, food consumption, volunteer interaction and documentation.  Performing Centrifugation & Separation Process of Plasma Samples with respect to the protocol, SOP’s and GCP Guidelines.  Performing Segregation of Plasma Samples with respect to the protocol, SOP’s and GCP Guidelines.  Performing Check-in, Check-out & Ambulatories with respect to the protocol, SOP’s and GCP Guidelines.  Reporting of the Adverse Events and Serious Adverse Event to the Sponsor and IRB/IEC.  Preparation of all pre-study, during study & post-study documents related to study execution, making them ready for monitoring & audits.  Preparation of Form 1572 & 3455.  Coordinating and being responsible for the preparation of Clinical Study reports, Protocols and summary reports as per regulatory requirements.  Co ordination with all concerned departments for proper planning & execution of studies.  Training of SOP’s and other study related activities to the New Joiners or Trainees.

As a QUALITY CONTROL Personnel  Review of ICF and Protocol before submission to IRB/IEC & review of IRB/IEC approval process.  Checking of study requirements before starting the study.  Verification of check-in, dosing, blood sample collection, Centrifugation, Plasma separation, Check- out And Ambulatories.  Verification of Study files, Essential documents, Source documents, and study reports for data accuracy.  Checking all log books related to the project for completeness and correctness of entries. CURRICULUM VITAE  Responsible for verification of study related documents for archival.

AREAS OF INTEREST . Clinical Research and Clinical Trials . Pharmacokinetics . Research and Development . Pharmacovigilence . Regulatory affairs

KEY ACHIEVEMENTS

 2.9 years Experience in Clinical research.  Goal-directed, results-oriented, professional with a strong clinical research background and education.  Trained on ICH – GCP.

STRENGTHS

 Honest and Dependable with Excellent Interpersonal skills.

 Team oriented Organized and Manage Time well.

 Work well under pressure, Flexible and Quick learner.  Possess Leadership skills, Enthusiastic and Assertive.  Friendly, have good Presentation skills.  Self confidence, Self Motivation and Challenging.

CERTIFICATIONS

 Successfully passed a Web-based examination covering all aspects of the “International Conference on Harmonization”-Good Clinical Practice Guidelines Course.  Participated and Successfully Completed the Web-based examination of “Open Access GCP Test”.  Attended Three Workshops on “ICH-GCP & Clinical Research” Conducted by Clinical Pharmacology Department at Axis Clinicals Ltd., Hyderabad.  Participated in “Bio-Medical Waste Management-Handling & Safe Disposal Options” Conducted by Sembramky Environmental Management Pvt.Ltd, in Trident Life Sciences, Hyderabad.  Attended Training on “First Aid Course” Conducted by Clinical Pharmacology Department at Axis Clinicals Ltd., Hyderabad.  Attended Training on “Adult Basic Life Support” Conducted by Clinical Pharmacology Department at Axis Clinicals Ltd., Hyderabad.  Participated in one day workshop/Training program in the “BASICS OF CLINICAL RESEARCH & ICH-GCP” at Vissannapeta, A.P. CURRICULUM VITAE  Poster presentation on “PHARMACIST INTERVENTION IN THERAPY OF MENINGITIS” at Sri Vishnu College of Pharmacy, Bhimavaram, A.P.  Poster presentation on “ANTI-CANCER ACTIVITY OF CAFFEINE” at Nimra College of Pharmacy, Vijayawada, A.P.  Participated in “NATIONAL SEMINAR” at Hindu College of Pharmacy, Guntur, A.P.

PERSONEL PROFILE

Father’s name : K.Durga Rao. Date of birth : 25.08.1987. Nationality : Indian. Passport No : G7536064 Marital status : Single. Linguistic abilities : English, Telugu, Hindi Computer literacy : Windows-7, MS office. Permanent Address : D.No: 50-4-25, Ayyappa Nagar, Gunadala, Polytechnic Post, Vijayawada-520008.

Present Address : LIG 409, 4th Floor, 1st phase, Road No-3, KPHB Colony, Hyderabad – 500072.

DECLARATION

I am confident that my association with the organization will be mutually beneficial and resourceful; giving an opportunity to severe your esteemed organization will prove my potential and work.

Place:

Date: (K.N.V. RAJESH)