BANDARU SHILPA
Round Rock,TX
Summary
Two years of Clinical Research experience along with Three years of experience in Microbial laboratories. Comprehensive knowledge of the procedures and clinical practice standards of Federal Drug Administration. Knowledge on monitoring procedures. Detailed knowledge of GCP and ICH guidelines including basic understanding of regulatory requirements. Comprehensive knowledge of Sop’s for site monitoring. Working knowledge on HPLC, GC and all wet lab instruments. Strong ability to identify and resolve vendor and client issues. Proficient in the use of MS office. Comprehensive problem solving abilities, excellent verbal and written communication skills, and willingness to learn, team facilitator, easy to adapt to new technologies
Overview
5
5
years of professional experience
1
1
Certification
Work History
Clinical Research Associate
Novartis
01.2011 - 03.2013
- Responsible for collecting data from clinical trials created for pharmaceuticals, biological, or Medical devices.
- Interacted with sponsors, CROs, investigators, vendors and subcontractors as needed.
- Coordinated the submission of regulatory documents to IRBs and ECs and other relevant authorities.
- Adhered to good clinical practices, operating procedures and regulatory requirements.
- Assessed incoming source documentation for accuracy and completeness against case report forms.
- Reviewed site regulatory binder to check collection procedures and completeness of paperwork.
- Supported quality control program by scheduling site assessment visits for project and conducting monitoring visits.
- Conducted site initiation visits and monitored ongoing studies at investigator sites.
- Obtained regulatory documents from study sites, review and enter into system.
- Reviewed documents for completeness and handled submissions of documents to the Trial Master File.
- Completed CRFs for Phase II/III trials
- Communicated and followed-up on required issues and action items in a timely manner.
- Participated in educational training, activities, and professional development programs.
Quality Analyst
Cipla Pvt Ltd
05.2009 - 12.2011
- Analyzed chemical, biological or microbiological products, raw materials, in-process materials, or stability samples in support of the company's quality program
- Interpreted and evaluated the analyses in terms of accuracy and precision and recommends corrective action where necessary
- Applied existing techniques and procedures with recommendations and implementation of modification for improved efficiency, or devises and develops new analytical methods and techniques
- Involved in establishing requirements for the transfer of methodology from R&D
- Performed qualitative tests or quantitative assays on samples using techniques that vary from use of standard analytical equipment to highly modern and automated instrumentation
- Frequent use and application of technical standards, principles, theories, concepts and techniques
- Provided solutions to a variety of technical problems of moderate scope and complexity
- performed sample preparation and provided general support in the analysis of samples.
- Compiled reports detailing findings from quality assurance testing activities.
- Worked under general supervision
- Followed established procedures
- Reviewed for soundness of technical judgment, overall adequacy and accuracy
- Contributed to the completion of milestones associated with specific projects.
Quality Analyst
Virchow Laboratories Limited
08.2008 - 03.2009
- Testing of microbiological samples and data review
- In-process checking and sampling of Intermediate, Bulk Finished and Finished Product
- Periodic Monitoring of control samples and their documentation
- Implemented on-line inspection system and procedures
- Produced sulfamethoxazole and analyzed it by chemical and microbial methods for its medicinal use
- Reported on Drug (sulfamethoxazole) analysis by using analytical techniques such as High Performance Liquid Chromatography, Gas Chromatography and FT-IR, etc
- Done Purity test, Organic volatile impurities and identification test has been done by using these techniques.
Education
Bachelor of Science - Biotechnology
Vinayaka Mission University
08-2009
Certification
Introduction to the principles and practice of Clinical research 2023-2024 from NIH (Office of Clinical Research Education & Collaboration Outreach)
Biological Skills
- RNA and DNA isolation
- CDNA library construction and screening
- DNA sequencing
- Protein isolation
- Protein gel electrophoresis
- Protein expression
- IgG and IgY purification
- Western and dot blotting
- Immunoprecipitation
- Immunofluoresce
- Mammalian cell culture
- Flowcytometry
- PCR
- Isolation, characterization and identification of bacteria, fungi from Clinical and environmental samples
- Serological techniques - ELISA, agglutination, precipitation, immunoelectrophoresis, blood cell count .etc.
- Microbiological analysis of food and water samples.
Presentations
- Given seminars during my course on agro bacterium mediated gene transfer, bacteriophage vectors, animal cloning and invitrofertilization and tumor suppressor genes.
- Given seminar on cancer treatment using stem cell technology at the interstate conference conducted by Cancer Institute, Mumbai, India.
- Presented paper in State level paper presentation in “Stem Cell Technology in curing Cancer" at Shastra College of Engineering, Thanjavur, India.
- Participated BIOVIN- 2008 State Level Seminar on “Recent Advances in Biotechnology” conducted by Dept. of Biotechnology AVIT, Chennai, India.
- Participated in State Level Seminar on “Recent approaches in Biomedical Sciences” conducted by Prof. Dhanapalan College for Women by Department of Biochemistry, Chennai, India.
- Participated in MIMA-CHEM 2006,statelevel Technical Seminar on “Modern Instrumental Methods of Analysis”conducted by vinayaka missions university ,India
Timeline
Clinical Research Associate
Novartis
01.2011 - 03.2013
Quality Analyst
Cipla Pvt Ltd
05.2009 - 12.2011
Quality Analyst
Virchow Laboratories Limited
08.2008 - 03.2009
Bachelor of Science - Biotechnology
Vinayaka Mission University
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