Seeking for the position of Clinical Data Researc Process in the medical field while merging into a globally focused organization that will purposefully utilize my qualifications while offering several opportunities to integrate personal enrichment with professional goals.
Summary of Qualifications
Clinical Research Operations
• Fundamental knowledge on Clinical Trial Process
• Methodically studied on Investigational New Drug (IND) application which requires as a submission to the Food and Drug Administration requesting permission to initiate a clinical study of a new drug product
• Good knowledge on monitoring visits
• Vital knowledge on Informed Consent Process
• Fundamental comprehension of ICH-GCP guidelines including basic understanding of regulatory requirements, Schedule Y
• Theoretical knowledge on Protocol, Investigator Brochure & SOP’s. Prepared SOP’s as a part of practical’s
Clinical Data Management
• Essential knowledge on Data Management Plan (DMP), involved in designing Case Report Form (CRF)
• Fundamental knowledge on Data Validation & Edit Check Specification
• Theoretical knowledge on Global Ruling & Data Clarification form (DCF) under Discrepancy Management
• Good Knowledge on Database Lock process & 21 CFR Part 11 guideline
• Principal knowledge on Safety Data Management
• Theoretical knowledge on Periodic Safety Update Report (PSUR), AE and SAE reporting
• Vital knowledge on Causality Assessment comprises of adverse event study
• Brief understanding on MedDRA and WHODD
• Ability to analyze and articulate the Narrative Writing.
Qualification Institute/ University/State Board Year of passing
APGDCRM CREMA- Affiliated with Jaipur National University 2012
M.Sc, Microbiology Andhra University 2006
B.Sc, Microbiology Andhra University 2004
Intermediate CGTM Jr College 2001
SSC APPM Model High School 1997
• Able to work under optimal supervision
• Excellent organization, planning and problem solving abilities
• Excellent analytical skills
• Established interpersonal and communication skills
• Effective time management skills
• Fluent in English and other local office languages both verbal and written
• Proficiency in computer
• Able to work effectively and efficiently in a matrix environment. Encouraging, Self motivating & Team Player
M Sc thesis:
Title: Transgenic tobacco revealing altered bacterial diversity in the rhizosphere during early plant development.
Client: Central Tobacco Research Institute, Rajahmundry, AP, India
Duration: 3 Months
Brief Description on Research: The rhizosphere constitutes a complex niche that may be exploited by a wide variety of bacteria. Bacterium-plant interactions in this niche can be influenced by factors such as the expression of heterologous genes in the plant. The objective of this work was to describe the bacterial communities associated with the rhizosphere region of tobacco plants, and to compare communities from transgenic tobacco lines with those found in wild-type (WT) plants. Samples were collected at two stages of plant development, the vegetative and flowering stages (1 and 3 months after germination).
The diversity of the culturable microbial community was assessed by isolation and further characterization of isolates. These analyses revealed the presence of fairly common rhizosphere organisms with the main groups Alphaproteobacteria, Betaproteobacteria, Actinobacteria and Bacilli. Shifts in bacterial communities occurred during early plant development, but the reestablishment of original community structure was observed over time.
The effects were smaller in rhizosphere than in rhizoplane samples, where selection of specific bacterial groups by the different plant lines was demonstrated. The data revealed that, although rhizosphere/rhizoplane microbial communities can be affected by the cultivation of transgenic plants, soil resilience may be able to restore the original bacterial diversity after one cycle of plant cultivation.
1. Conducted a presentation on IND to the Principal of faculties at CREMA. Received accolades for the design and presentation.
2. Won several auspicious awards in quiz competitions held at College semester level.
3. Attended Biofest event and presented a model on HIV AIDS organized by V.S. Lakhsmi women’s college Kakinada, Andhra Pradesh conducted for 3 days. Received appreciations for the presentation.
4. Participated in Work shop on Microbial & Medical Biotechnology conducted by Dept of Microbiology, Dr. V.S. Krishna Govt. College, Visakhapatnam, Andhra Pradesh.
5. Prepared a running concept on a topic called Biofilms, and presented to the Department of Mico-Biology & respective HOD successfully as a part of MSc curriculum. Achieved good appreciations from the Microbiology Department.
6. Involved in sports like Badminton, Basketball and Hockey conducted by School authorities on various occasions.
# 14, 2nd Cross, Happy Gardens,
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Date of Birth: 24th July 1982
Languages known: English, Hindi and Telugu