Clinical Research associate

***E **th street, N**N, New York, NY *****

RUCHITA MEHTA, MS, CCRP Tel: 267-***-**** | Email: *********@*****.***

EDUCATION: CRA Professional Development Program, Kriger Research Center, Inc.Canada 2007

Thomas Jefferson University Hospital, Philadelphia, PA

Masters in Microbiology and Immunology (with thesis defense), 2005

GPA – 3.63

Drexel University, Philadelphia, PA Bachelor of Science in Biological Sciences, Biotechnology, 2002

Dean’s list scholarship

GPA – 3.6,

SOFTWARE: MS Office, MS Access, Windows XP, WinNonlin, Prism, NONMEM, ICIS SSO, OncoLog

CERTIFICATIONS: GCP, HIPPA, CITI

MEMBER: SoCRA (Society of Clinical Research Associates), Children’s Oncology Group (COG)

EXPERIENCE

06/08 – present NYU Langone Medical Center, Hassenfeld Children’s Center for Blood Diseases and Cancer, NY

Clinical Research Associate/Coordinator/Regulatory Specialist/Data Manager for Pediatrics, Oncology

• Coordinate and maintain over 30+ Pilot, Phase I, II and III pediatric and adult trials for Osteosarcoma, Ewing’s sarcoma, Rhabdomyosarcoma, Neuroblastoma, Hodgkin’s, Renal, Hepatoblastoma and CNS clinical trials for Children’s Oncology Group (Sponsor)

• Lead CRA for CNS trials, Headstart III (multi-center trial initiated by Children’s Hospital of Los Angeles) and PBMTC ONC032 (NYU in-house, investigator initiated multi-center trial). Coordinate regulatory compliance, screening, enrollment, data compliance and any adverse event reporting. Responsible for bi-annual DSMC and Progress reports for the study.

• Conduct study initiation, site preparation and study maintenance for industry trials

• Ensures the accurate execution of research protocols in accordance with FDA, GCP/ICH and HIPPA guidelines

• Responsible for submission of data forms for numerous patients on trials, both in active treatment and in follow-up

• Ensure Adverse Events are reported appropriately, accurately and in a timely manner and that follow-up activities are conducted as necessary

• Design Informed Consent Documents

• Acquire specific clinical and therapeutic knowledge with the help physicians and NP’s

• Accountable for screening, enrolling and maintaining 100+ patients on study and in follow up including reporting adverse events to regulatory bodies in a timely manner

• Provide budget negotiation/special funds and billing plans for financial feasibility

• Oversee pathology lab technician in biology study requirements and shipping biologic specimens/materials, coordinated drug supply (NIH, industry)

• Responsible for the overall coordination of the audit system for clinical research

• Train medical students/residents/physicians in opening new studies and data collection

• Attend annual COG conferences, staying abreast of latest study openings and research tactics

• Database management: Coordinate data for statistical analysis, research protocols, articles, abstracts and develop presentations for NIH and physicians

• Attend monthly tumor board meetings to discuss pathology and radiology for newly diagnosed patients

4/06-6/08 Children’s Hospital of Philadelphia, PA

Clinical Pharmacology & Therapeutics

• Part of a major neuroblastoma project with the objective of finding optimum synergy and sequence of administration for retinoic acids and chemotherapeutic drugs. With the aid of our physicians and in vivo specialist, the drug responses and their synergy with retinoids are chosen and used in the clinic for the best chemotherapeutic response.

• Optimize and conduct cell proliferation and combination experiments with cytotoxic compounds against various pediatric cancer lines including Osteosarcoma, Ewing’s Sarcoma, Neuroblastoma, Rhabdomyosarcoma, Leukemia, Lymphoma

• Clinical data management - WinNonlin, Prism, NONMEM, PK/PD models and data analysis.

6/05-4/06 Johnson & Johnson, Centocor Radnor, PA

Bioassay Development, Associate Scientist II

• Development and optimization of SK-BR-3 cell based bioassay for testing the potency of F5-PEG-DSPE for Doxil toxin (Alza pharmaceutical, CA) used for breast cancer under GLP environment.

• UT-7 cells serum free for the evaluation of propriety drug development.

• Determination of CNTO607 bioactivity with a TF-1 cell based bioassay.

• Optimization, Qualification and Validation of CNTO95 assay development.

6/04-6/05 Merck & Co., Inc. West Point, PA

Pharmaceutical Research & Development, Pre-Clinical Scientist

• Executed a Varicella cell based potency assay, TCID-50 for mumps qualification, ELISA.

• Supported manufacturing feasibility studies of quadrivalent M-M-R-V (Measles, Mumps, Rubella and Varicella), ProQuad®.

• Assisted in all stages of preparation of various Zosta-Vax® process development studies.

1/03-5/04 Thomas Jefferson University, Philadelphia, PA

Department of Pathology, Anatomy and Cell Biology

• Lead the research project on alcohol & IGF1 signaling supported by the NIH grant.

• Preparation of permanent cell line using G418, Protein extraction, Immunoprecipitation

• PKC alpha clones expressing green fluorescence protein, Western blots

• Primer design, Cloning, Plasmid purification Maxi and Mini Preps, Transfection, PCR, Vaccinia virus propogation

PUBLICATIONS-

• PKC alpha-dependent regulation of the IGF1R in adult and embryonic rat cardiomyocytes: Ruchita Maniar, Michele Solemn, Anna Pecherskya, Richard Ila. Molecular and Cellular Biochemistry: July 2005, Vol 275, 15-24.

• Chronic alcohol exposure alters IGF1 signaling in H9c2 cells via changed in PKC delta. Richard Ila, Michele Solemn. Acknowledgments Ruchita Maniar. Alcohol: 39(2006) 169-178

• Optimization of Cell Adhesion Bioassay for CNTO95, a fully human anti-αvβ3 integrin monoclonal antibody. Tong Yuan, Bing Hu, Ruchita Maniar, Sandra Fenton. Pharmaceutical Development, Centocor, J&J R&D, PA 19087, USA.

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