Summary
Overview
Work History
Education
Skills
Languages
Timeline
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Parisha Vora

Santa Rosa,CA

Summary

Logical and perceptive CRS with 6+ years of experience leading research. Instrumental in conducting clinical trials. Proven track record of working strategically with cross-functional teams to optimize business and clinical outcomes. Results-oriented with attention to detail and focus on driving continual improvements in medical science.

Overview

6
6
years of professional experience

Work History

Sr. Clinical Research Specialist

Medtronic
Santa Rosa, CA
07.2021 - Current
  • Contributes to the management of a high priority post-market trial in the U.S. geography, ensuring strict adherence to Standard Operating Procedures (SOP), Good Clinical Practice (CGP) guidelines, and pertinent country-specific regulations.
  • Collaborates closely with cross-functional internal and external stakeholders to execute study and meet internal project milestones while maintaining regulatory compliance and high data quality.
  • Provided input on protocol design to optimize patient safety, efficacy outcomes, timeline, budget, regulatory compliance for a large, post-market trial, outlining key methodologies and objectives.
  • Conducts comprehensive site qualification and initiation visits with customers, ensuring clinical sites are sufficiently equipped to be complaint with study protocol.
  • Proactively identify barriers to enrollment and risks to study progress by collaborating with stakeholders to implement effective solutions and mitigate issues.
  • Perform quality control checks of data entry into databases to ensure accuracy prior to analysis.
  • Maintain communication with sites regarding study status updates, changes in protocol requirements.
  • Conduct site visits to evaluate performance of sites participating in studies according to applicable regulations or guidelines.
  • Organize and manage clinical trial data collection, analysis, and reporting.
  • Participate in investigator meetings, Research coordinator meetings to discuss progress of studies and address any issues that arise.
  • Manage vendor documents, budgets, quality of output and ongoing trial support

Clinical Research Specialist

Medtronic
Santa Rosa, CA
03.2018 - 07.2021
  • Analyzed primary and secondary data to ensure accuracy and completion of study objectives.
  • Generated Annual Progress Reports summarizing study results for presentation at scientific conferences or publication in medical journals.
  • Monitored adherence to Good Clinical Practices throughout all phases of a study.
  • Involved in managing a Class Action product recall from the clinical standpoint as well as participated in multiple mock audits and BIMOs.
  • Tracked participant recruitment progress against enrollment targets.
  • Reviewed adverse event reports submitted by sites during trials and reported findings back to IRBs/FDA.
  • Collaborated closely with medical personnel such as physicians and nurses to collect necessary data from patients during the course of a study.
  • Coordinated with medical staff to ensure compliance with protocol requirements.
  • Assisted in developing marketing materials used by sponsors when recruiting participants for studies.

Associate to Research Director

French Embassy in India
Mumbai , India
  • Managed joint research programs in STEM between France and India.
  • Helped manage and disperse the grants and funding received from local governments.
  • Collaborated with the top universities in the two countries to develop joint scientific programs and help with knowledge transfer and collaboration.
  • Researched on up and coming research requirements to develop programs to build future infrastructure.

Education

Diploma - Clinical Research Conduct And Management

University of California Berkeley
01-2017

Master of Commerce -

University of Mumbai
Mumbai India
01-2008

Skills

Pharmacovigilance, Clinical Data Interpretation, Clinical Trial Management, Medical Devices, GCP, Project Management, Customer Relationship Management, ISO14155, Cross-Functional Coordination, Vendor Management, Clinical Trial Management Systems, Microsoft Office, Critical Thinking, Analytical Skills, Problem-solving aptitude, Teamwork and Collaboration

Languages

French
Full Professional
Hindi
Full Professional

Timeline

Sr. Clinical Research Specialist

Medtronic
07.2021 - Current

Clinical Research Specialist

Medtronic
03.2018 - 07.2021

Associate to Research Director

French Embassy in India

Diploma - Clinical Research Conduct And Management

University of California Berkeley

Master of Commerce -

University of Mumbai

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Parisha Vora