Summary
Overview
Work History
Education
Skills
Timeline
Generic

Rinsi Gupta

Sunnyvale

Summary

Organized, detail oriented and clinical trial certification holder with 2+ years of experience in research data entries, conducting surveys and Vista EPR and LIMS system. Also, well versed in communicating with healthcare professionals. Knowledge of subject recruitment, patient screening, ICH/GCP guidelines and Trial Master File.

Overview

14
14
years of professional experience
3
3
years of post-secondary education

Work History

Clinical Research Associate

Natera
4 2022 - Current
  • Review data queries and listings and worked with study centers to resolve data discrepancies.
  • Support specimen management by tracking cases through LIMS from accessioning until reports are sent and case is closed
  • Order, Monitor and coordinate incoming and outgoing kit supply shipments
  • Prepare monthly and weekly return result excel sheet for RUO, Renasight, Prospera research studies and return them to the sites
  • Update the Halloran Kidney and Heart tracker and adding the result in RedCape EDC system.
  • Monthly Prospera and Renasight IIT fiance sample updates in IIT Dashboard.
  • Coordinating and managing the Natera's volunteer sample collection study
  • Add Invoices in invoice tracker, in study folder and on ITT dashboard as receive from site.
  • Issue, track and close queries (DCFs), track pending results and enable prompt reporting, Test Not Performed (TNP), testing turn-around-times (TAT), etc
  • Performs other duties as assigned
  • Participated thorough site feasibility assessments for potential clinical trial participation, identifying suitable sites for studies.
  • Maintained awareness of industry trends by attending conferences and participating in relevant professional development opportunities.
  • Implemented new technologies in the management of clinical trials, streamlining data collection and reporting processes.
  • Occasionally educate and consent participants for research studies
  • Partner with other research and development groups at Natera to achieve deliverables
  • Coordinate review of data listings and preparation of interim/final clinical study reports
  • Provides operational and logistical support for one or more clinical trials/studies or initiative
    projects
  • Managed multiple projects simultaneously while maintaining a high level of attention to detail and meeting deadlines.
  • Identified areas for process improvement within clinical trials, implementing changes to enhance overall project efficiency and quality.
  • Enhanced data quality by closely monitoring study progress and ensuring accurate data collection.
  • Streamlined clinical trial processes for increased efficiency, utilizing strong organizational skills.
  • Collaborated with cross-functional teams to successfully meet project timelines and deliverables.

Clinical Data Operator

Natera
10.2021 - 04.2022
  • Accession Panorama, Horizon and Prospera samples with high accuracy and efficiency (current accuracy- 98.27%).
  • Create new orders on Laboratory Inventory Management System (LIMS) and perform necessary checks to ensure proper accessioning.
  • Ensure that the information in LIMS is up-to-date.
  • Scanned test requisition forms and attached paperwork. Ensure that all paperwork belong to patient and upload to the case.
  • Protect patient health information (PHI) at all times to ensure compliance with HIPAA and privacy policies.
  • Maintain familiarity with standard operating procedures (SOP) and quality standards determined by the clinical laboratory.

Cancer Registrar Assistant (volunteer)

VA Palo Alto Health Care System
06.2019 - 09.2021
  • Cancer patient follow up: Used Computerized Patient Records (CPRS) to read and pull patients data and make valid entries into Vista A (OncoTrax Cancer Registry).
  • Trained in organizing Tumor Board meetings (handle logistics and assist with agendas)

Research Assistant (volunteer)

Stanford Cancer Center
09.2019 - 03.2020
  • Performed data entries into Excel spreadsheets.
  • Organized, sorted, and analyzed the clinical data files.
  • Received training to review and write IRB continual renewal form
  • Assisted with writing a telephonic and email script for research study.
  • Extracted data from REDCape and prepared excel master file for data analysis.
  • Transcribed recorded interviews.
  • Conducted telephonic surveys to gather information about care experience of cancer patients.

Research Supervisor

HarvestPlus
08.2010 - 11.2010
  • Reviewed research protocol for background study.
  • Implemented nutrition awareness and education strategies focused on the consumption of biofortified crops among population in the area of operation.
  • Directed and supervised production and dissemination of food recipes based on biofortified crops while acknowledging the culture of the area of operation.
  • Prepared research and projects reports.
  • Supervised and trained research assistants for conducting surveys.
  • Performed one-on-one surveys and collected data on socio-economic status, morbidity profile, and 24-hour dietary recall.

Education

Master of Science - Food Science and Nutrition

Sardar Patel University
05.2006 - 05.2008

Certificate: Clinical Research Conduct and Management - Biological Science

UC Berkeley
San Francisco, CA
01.2019 - 12.2019

Skills

Microsoft Excel and Word

Natera LIMS System

Interpersonal Communication

Attention to details

Maintain Regulatory Binder(eTMF)

HIPPA Guidelines

Timeline

Clinical Data Operator

Natera
10.2021 - 04.2022

Research Assistant (volunteer)

Stanford Cancer Center
09.2019 - 03.2020

Cancer Registrar Assistant (volunteer)

VA Palo Alto Health Care System
06.2019 - 09.2021

Certificate: Clinical Research Conduct and Management - Biological Science

UC Berkeley
01.2019 - 12.2019

Research Supervisor

HarvestPlus
08.2010 - 11.2010

Master of Science - Food Science and Nutrition

Sardar Patel University
05.2006 - 05.2008

Clinical Research Associate

Natera
4 2022 - Current

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