Summary
Overview
Work History
Education
Skills
Certification
Timeline
Generic

Pallavi Vaidya

Sacramento,CA

Summary

Certified clinical research professional (ACRP-PM and ACRP-CP) with over eight years of experience in clinical research focusing on cardiovascular and structural heart phase II-IV device trials. Expert in navigating the entire lifecycle of trials using systems such as CTMS, e-TMF, and EDC, from site qualification (SQV) to closeout visits (COV). Highly organized and thorough with good planning and problem-solving abilities.

Overview

13
13
years of professional experience
1
1
Certification

Work History

Senior Clinical Research Coordinator (Surgery)

UC Davis Health
05.2022 - Current
  • Administer, manage, and oversee operational aspects of clinical trials in cardiac and vascular surgery departments in accordance with standard operating procedures (SOP) and Good Clinical Practice (GCP). Conditions worked on included Mitral Regurgitation, A-Fib, PAD, AAA, HF, and Thoracic Arch Disease.
  • Provide project management support for investigators and residents, specifically during their Investigational Device Exemptions (IDE) application submissions, compliance submissions, CMS approval, and trial execution.
  • Manage Budgets, timelines, regulatory/IRB approvals, and study agreements.
  • Participate in Site Qualification Visits (SQV), Site Initiation Visits (SIV), Site Monitoring Visits (SMV), and Closeout Visits (COV)
  • Served as a liaison between external vendors, such as CROs, sponsor teams, and external labs, to ensure seamless trial execution and management.
  • Managed study parameters using the CTMS-OnCore system to enhance data tracking and reporting.
  • Increase patient retention rates by establishing solid relationships with participants through effective communication and follow-up. Design and execute patient recruitment and screening strategies along with the Principal Investigator.
  • Authored study-related clinical documents, including Protocols, Case Report Forms (CRFs), Informed Consent Forms (ICFs), and patient record forms.
  • Create and manage data capture system EDC-REDCap for investigator-initiated studies/trials.
  • Enhanced data quality by closely monitoring study metrics and resolving discrepancies promptly.
  • Responsible for IRB and regulatory submissions for research studies, such as FDA annual reports and IRB initial, annual, and close-out reviews
  • Record and report adverse events (AEs), serious adverse events (SAEs), and protocol deviations to IRB and sponsors
  • Develop project schedules, targets, measurements, and accountability frameworks to manage project milestones
  • Manage and track study payments and device accountability for trials
  • Monitor/audit the work of departmental research coordinators and research assistants to ensure study compliance
  • Lead, mentor, and train team members, CRCs, and Jr Specialists.

Clinical Research Coordinator -2 (Structural Interventional Cardiology)

Stanford University
01.2022 - 04.2022
  • As a team lead, I led the team of coordinators for the execution of various structural interventional cardiology clinical trials, specifically TVAR and Transcatheter Mitral and tricuspid therapies for conditions such as Mitral Regurgitation and Tricuspid Regurgitation
  • Implemented and planned data management for various trial protocols
  • Developed and managed systems to organize, collect, report, and monitor data collection
  • Extract, analyze, and interpret data
  • Responsible for IRB submission and IRB communications for structural heart studies
  • Monitored study timelines and ensured timely resolution of any anticipated issues and queries
  • As a lead, assessed financial and contract components for trial
  • Managed device accountability for the research trial
  • Coordinated with principal investigators, study sponsors, and monitors.

Clinical Research Coordinator (Interventional Cardiology)

Mission Cardiovascular Research Institute
01.2019 - 01.2022
  • Implemented clinical trial protocols for Interventional cardiovascular device/ drug studies by ensuring compliance with protocol requirements, site SOPs, and regulatory standards
  • Conditions worked on PAD, CAD, Carotid artery, and Renal artery diseases
  • Managed and scheduled protocol-related patient visits and assessments
  • Collected trial-related data and maintained source documentation
  • Resolved, tracked queries, and reconciled data in EDC systems
  • Responsible for site IRB submissions and communications (Initial approvals, study closeout, continuing review, reporting of adverse events and protocol deviations, etc.)
  • As site lead participated in IRB audits and FDA inspections
  • Managed drug/Device and study supplies accountability
  • Involved in discussions, study budget and contract and feasibility questions activities for the site
  • Authored the site’s standard operating procedures (SOPs) and maintained the site’s regulatory binders.

Technical Writer and Lead Quality Assurance Reviewer

ADTS Professional Services
01.2012 - 03.2018
  • Penned Drugs and Devices market research reports by comprehensively analyzing regulatory aspects, new drug/device/technology developments, and clinical research
  • Experienced in analyzing and inferring various literature databases/websites, such as ClinicalTrials.gov and PubMed, and patent databases, such as USPTO
  • As team lead, generated queries for reports written by team members to clarify and improve quality and integrity of data
  • Monitored project schedule and mitigated any issues.

Assistant Clinical Study Coordinator (Gastroenterology)

Leading Hepatologist (Dr. Gupte) from Mumbai, India

Assistant Manager – Production Planning and Inventory Management

Strides Pharma

Production Planning Executive – ERP (SAP) and Total Quality Management (TQM) Systems Implementation Core Team

Burroughs Wellcome India Ltd

Research Associate - Formulations

Hindustan Ciba-Geigy Ltd

Education

Bachelor of Pharmacy (BPharm) -

Poona College of Pharmacy
Pune-India

Post Graduate Certification in Clinical Research and Clinical Data Management (CRCDM) -

University of Pune
Pune-India

Skills

  • Certified Clinical Trial Project Management
  • Certified Clinical Research Professional
  • ICH GCP Regulations
  • Medical Device Trial management
  • Cardiovascular Phase II to Phase IV trials
  • Design, Plan, and Execute research studies
  • IRB Submissions and Regulations
  • FDA Audit Requirements
  • Regulatory Compliances
  • FDA-IDE Submissions
  • Protocol, Informed Consent Form (ICF), Case Report form (CRF), and Standard Operating Procedure (SOP)writing
  • Microsoft Office applications (Excel, PowerPoint, Word, MS Project) and SharePoint, Smartsheet
  • E-TMF, CTMS, EDC Systems
  • Healthcare and Pharmaceutical Industry knowledge
  • Strong problem-solving and critical-thinking skills
















Certification

  • Certified Clinical Research Professional (ACRP-CP)
  • Certified Project Management -Clinical Research (ACRP-PM)

Timeline

Senior Clinical Research Coordinator (Surgery)

UC Davis Health
05.2022 - Current

Clinical Research Coordinator -2 (Structural Interventional Cardiology)

Stanford University
01.2022 - 04.2022

Clinical Research Coordinator (Interventional Cardiology)

Mission Cardiovascular Research Institute
01.2019 - 01.2022

Technical Writer and Lead Quality Assurance Reviewer

ADTS Professional Services
01.2012 - 03.2018

Assistant Clinical Study Coordinator (Gastroenterology)

Leading Hepatologist (Dr. Gupte) from Mumbai, India

Assistant Manager – Production Planning and Inventory Management

Strides Pharma

Production Planning Executive – ERP (SAP) and Total Quality Management (TQM) Systems Implementation Core Team

Burroughs Wellcome India Ltd

Research Associate - Formulations

Hindustan Ciba-Geigy Ltd

Bachelor of Pharmacy (BPharm) -

Poona College of Pharmacy

Post Graduate Certification in Clinical Research and Clinical Data Management (CRCDM) -

University of Pune

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