RAJESWARI GHOSH

** ****** ***, ******, **, ***** 716-***-**** adli1x@r.postjobfree.com

PROFESSIONAL SUMMARY

•Experience working in CRO environment,

•Hands-on experience working on EDC systems like Medrio,

•Working experience on,

oCreation and review of Data Management Plan,

oCreate Edit Checks Specification, and UAT programmed edit checks,

oPerform data cleaning activities, such as issuing & closing queries,

oGenerate progress report for study team,

•Sound understanding of drug development and data management processes,

•Working knowledge and practical understanding of ICH GCP regulations and guidelines relating to Drugs, Biologics and Medical Devices,

•Involved in developing/reviewing in-house CRF standards,

•Extensively strategic, detail oriented, creative and quality oriented approach to work,

•Excellent interpersonal and written/verbal communication skills.

ADDITIONAL SKILLS

•In-depth knowledge of ICH GCP guidelines

•CRF designing

•Protocol review

•Scientific literature review

•Analysis and presentation of experimental data

EDUCATION

STATE UNIVERSITY OF NEW YORK AT BUFFALO Buffalo, NY

Master of Science (M.S.) Biomedical Engineering (Aug 2018-Jun 2020)

NATIONAL INSTITUTE OF TECHNOLOGY AGARTALA Agartala, India

Bachelor of Technology Bioengineering (May-2014-Aug 2018)

EXPERIENCE

IRI (CRO) Edison, NJ

Clinical Data Associate July 2020 – Present

•Perform protocol review for the assigned study

•Assist with CRF designing in EDC system, to ensure that CRFs are consistent with protocol and CRF standards.

•Assist with drafting and review of Data Management Plan (DMP) for the assigned study

•Perform 'test' data entry to validate eCRFs in the EDC system

•Assist with creating and review of Edit Check Specification document

•Perform UAT of edit checks by entering 'test' data to validate edit checks

•Ensure all UAT documentation is complete, and edit checks are ready to be 'Moved to production'

•Perform query management i.e. review system queries, site's response, and close-out or re-query accordingly

•Perform manual data review and issue manual queries for discrepant data

•Assist in the management and review of external local lab entries

•Perform reconciliation and query management of external lab data listings

•Prepare and distribute Study Progress Reports to the study team on a periodic basis

UNIVERSITY AT BUFFALO Buffalo, NY

Graduate Research Assistant Aug 2019 - Jun 2020

•Modeled volume birdcage coils of resonant frequencies corresponding to 1.5 T, 3T, 4.7T, 5.4T, and 7T using COMSOL Multiphysics software

•Simulated the thermal changes induced by the birdcage coils in a human head phantom and spherical phantom with properties of biological tissues, after varying periods of exposure

•Was responsible for comparative testing of softwares suitable for the research needs of the lab and facilitation of purchase of appropriate software from vendor

UNIVERSITY AT BUFFALO Buffalo, NY

Graduate Student Researcher Jan 2019 - Jul 2019

•Investigated the biochemical and mechanical properties of gelatin-based colloidal gels to assess their biocompatibility as a suitable cell environment for human Mesenchymal stem cells via fluorescent microscopy, image analysis, UV-vis spectrophotometric analysis, cell culture, protein release and internalization assays and rheology studies.

•Prepared and stocked all laboratory solutions and reagents efficiently.

•Reviewed relevant scientific literature and optimized experimental protocols.

•Organized, analyzed research data graphically and statistically and presented them to supervisor and colleagues at weekly laboratory meetings.

•Provided knowledge transition to new lab members; conducted training on project-specific practices.

BIOTECH HUB, C.O.F. Agartala, India

Summer Intern May 2017 - Jun 2017

•Assisted the team of researchers of the department to study and quantify the differential tissue expression of Aquaporin gene in samples of tissue from Clarius batrachus using qRT-PCR and DNA sequencing to investigate the role of Aquaporin in reproduction.

•Kept accurate and up-to-date documentation of testing results.

VIRAL RESEARCH AND DIAGNOSTICS LAB, A.G.M.C. Agartala, India

Summer Intern May 2016 - June 2016

•Managed and screened over 20 blood samples for Tuberculosis virus via PCR method each day.

•Gained understanding of various instruments employed in the lab – Usage, maintenance, functioning and safety.

Contact this candidate