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)