Summary
Overview
Work History
Education
Skills
Certification
Websites
Timeline
Generic

Poorva P. Patil

Boston

Summary

Adaptable clinical research coordinator with proven ability to manage and oversee clinical trials. Expertise in coordinating research teams, ensuring protocol compliance, and managing participant recruitment and data collection. Strong organizational skills enable efficient multitasking and accurate documentation. Demonstrated success in delivering high-quality results in fast-paced environments.

Overview

5
5
years of professional experience
1
1
Certification

Work History

Clinical Research Coordinator II

Beth Israel Deaconess Medical Center & Harvard Medical School
Boston
09.2024 - Current
  • Oversaw complete participant lifecycle in multi-site Clozapine trial, ensuring compliance from recruitment to study close-out.
  • Led informed consent process adhering to ICH-GCP and IRB standards; managed AE logs and regulatory documentation.
  • Prepared and submitted IRB amendments and continuing reviews while overseeing protocol updates and study timelines.
  • Conducted EEG, eye-tracking, and cognitive assessments; anonymized and submitted data to central analysis teams.
  • Collaborated with investigators, vendors, and lab staff; facilitated weekly meetings with structured agendas for effective communication.

Regulatory Affairs Associate (Capstone Project)

Purcell LLC
04.2024 - 06.2024
  • Developed regulatory strategy for a Smart Inhaler and AI-SaMD in accordance with MHRA and EU MDR guidelines.
  • Drafted SOPs, clinical trial application (CTA) in eCTD format, and supported ISO 14155:2020 compliance.
  • Remote

Clinical Operations Intern

KEM Hospital – Dept. of Clinical Pharmacology
Mumbai
01.2021 - 03.2022
  • Managed TMF and coordinated IRB submissions for Phase III Meningitis trial.
  • Conducted informed consent process and assisted with patient screening, vitals, and data entry.
  • Prepared audit-ready documentation and supported EC/IRB meetings, ensuring protocol adherence.

Drug Safety Intern

KEM Hospital – Dept. of Pharmacovigilance
Mumbai
12.2020 - 10.2021
  • Submitted 100+ ICSRs using VigiFlow; ensured regulatory compliance per CDSCO and GVP standards.
  • Analyzed AE/SAE data, conducted seriousness assessments, and prepared reports for regulatory bodies.

Education

MS - Regulatory Affairs

Northeastern University
Boston, MA
06.2024

MS - Pharmaceutical Medicine

Seth G.S. Medical College and KEM Hospital
Mumbai, India
04.2022

BS - Microbiology

Mumbai University
Mumbai, India
04.2019

Skills

  • Regulatory Submissions (IND, CTA, eCTD)
  • ICH-GCP
  • IRB & EC Coordination
  • TMF Management
  • Clinical Trial Operations
  • MHRA & EU MDR
  • VigiFlow
  • AE/SAE Reporting
  • Microsoft Office Suite
  • Smartsheet
  • REDCap
  • Box
  • EPIC
  • Document Control
  • SOP development
  • Audit Prepration

Certification

  • Good Clinical Practice (GCP) – NIDA (2023)
  • US FDA Safety Evaluation of Generic Drugs (2023)
  • Research Methodologies – MUHS (2020)
  • Project Management – GlobalShala (2022)

Websites

Timeline

Clinical Research Coordinator II

Beth Israel Deaconess Medical Center & Harvard Medical School
09.2024 - Current

Regulatory Affairs Associate (Capstone Project)

Purcell LLC
04.2024 - 06.2024

Clinical Operations Intern

KEM Hospital – Dept. of Clinical Pharmacology
01.2021 - 03.2022

Drug Safety Intern

KEM Hospital – Dept. of Pharmacovigilance
12.2020 - 10.2021

MS - Regulatory Affairs

Northeastern University

MS - Pharmaceutical Medicine

Seth G.S. Medical College and KEM Hospital

BS - Microbiology

Mumbai University

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Poorva P. Patil