Yashvi Patel
Acworth,United States
Summary
Clinical Research Associate (CRA) and licensed pharmacist with hands-on experience in hospital-based oncology trials (Phase I–III). Skilled in site coordination, regulatory compliance (GCP, ICH, FDA), and management of study documents (TMF, 1572s, ICFs). Proficient in site initiation, patient tracking, and data monitoring through EDC systems. Also, a results-driven Quality Assurance and Compliance Specialist with extensive experience in validation, quality oversight, and regulatory compliance within GMP environments. Proven expertise in reviewing and approving validation protocols, managing lifecycle validation processes, and ensuring adherence to regulatory and corporate standards. Skilled in leading cross-functional teams, conducting root cause analysis, and implementing corrective and preventive actions (CAPA). Adept at managing validation deliverables, risk assessments, protocols, and reports, while ensuring compliance with GxP requirements.
Overview
9
9
years of professional experience
1
1
Certification
Work History
Hospital Pharmacist/Clinical Research Associate
Mount Sinai Hospital
Toronto, Canada
09.2022 - 12.2024
- Supported Phase I–III trials at Mount Sinai Hospital, collaborating with Princess Margaret Cancer Centre
- Managed 50+ electronic Case Report Forms (CRFs) and data validation processes, ensuring 99% data accuracy and timely collection in EDC systems (Medidata)
- Oversaw patient tracking and data quality for 100+ trial participants, resolving queries and ensuring protocol compliance
- Reviewed and maintained 150+ regulatory documents (ICFs, Financial Disclosures) in adherence to GCP, FDA, and NCI standards
- Coordinated clinical study logistics, including source documentation reviews, patient scheduling, and site initiation visit (SIV) preparation
- Supported study recruitment efforts, increasing participant engagement by 15%, contributing to higher retention rates and reduced dropout rates
- Clinical Trials:
- Princess Margaret Phase I Consortium (PMP1C) – Early-phase trial investigating novel oncology treatments
- A Study to Assess the Safety and Efficacy of AZD7789 in Participants with Advanced or Metastatic Solid Cancer (NCT04931654)
Clinical Pharmacist
Shoppers Drug Mart Pharmacy
New Liskeard, Canada
08.2020 - 08.2022
- Prescribed treatments for minor ailments, reducing physician referrals by 25% and improving patient access to care
- Provided medication consultations to 50+ patients daily, optimizing adherence and improving therapy outcomes
- Led diabetes management clinics, educating 500+ patients annually and improving glycemic control through personalized care plans
- Collaborated with physicians to resolve complex medication issues, reducing prescription-related errors by 20%
Quality Assurance and Compliance Specialist
BioScript Solutions- A&D Wholesale
Mississauga, Canada
06.2019 - 07.2020
- Designed and optimized quality systems, procedures, and processes to ensure compliance with regulatory standards and operational efficiency
- Managed the review and approval of validation deliverables, including protocols, risk assessments, and reports, ensuring alignment with corporate and regulatory policies
- Led the cooler expansion project, completing IQ, OQ, and PQ phases independently, ensuring compliance with regulatory standards and project timelines
- Conducted thermal chamber programming and lane studies to assess product quality and ensure validation of temperature-controlled processes
- Supported internal audits, identified areas for improvement, and implemented corrective actions to enhance compliance and operational performance
- Reviewed and approved SOPs, protocols, and quality system records, ensuring accuracy and compliance with GMP standards
- Utilized Navision software for operational tasks, streamlining processes and improving data management
- Facilitated vendor license approvals and system setup for new items, ensuring compliance with regulatory requirements
QA Compliance Seasonal Associate
Innomar Strategies
Milton, Canada
01.2017 - 10.2019
- Reviewed and developed validation reports for temperature-controlled packaging units, ensuring compliance with pharmaceutical cold chain requirements
- Programmed temperature sensors using Cryopak software (Escort Console Plus/Pro) and conducted lane studies to validate temperature pack-outs (Aerosafe, Credocube)
- Monitored and analyzed temperature data for storage facilities, investigating OOS conditions and ensuring compliance with regulatory standards
- Drafted, evaluated, and reviewed Annual Product Quality Reports (APQRs), identifying adverse trends and ensuring regulatory compliance
- Tracked stability lots and entered stability data into the Stability Program, ensuring product quality over time
- Supported the change control process for Quality System Records, maintaining GMP compliance and ensuring timely approvals
- Collaborated with internal and external stakeholders to provide regulatory guidance and support for drug submissions and compliance matters
Regulatory Affairs Associate – Compliance
Amneal Pharmaceuticals
Ahmedabad, India
07.2015 - 09.2017
- Prepared and reviewed regulatory submission documents for 10+ clinical trial applications, ensuring 100% on-time submissions in compliance with ICH guidelines and regulatory bodies
- Managed trial master file (TMF) and site documentation for 5+ clinical studies, maintaining 95% audit compliance
- Coordinated with R&D, QA, and CRO teams to compile technical documentation and respond to 50+ regulatory queries, reducing resolution time by 15%
- Assisted in tracking clinical study budgets and contracts, ensuring timely approvals and adherence to regulatory requirements
Education
Master of Science - Translational Pharmacology and Clinical Research
Ohio State University
07.2025
Non-Degree Seeking Classes - Pharmaceutical Sciences
University of Toronto
Toronto, ON, Canada06.2019
Bachelor of Pharmacy -
L.J. Institute of Pharmacy (GTU)
Ahmedabad, India06.2017
Skills
- Clinical Trial Oversight
- Site Operations Management
- Compliance Management
- GCP and GMP Adherence
- Implementing Corrective Actions
- Preventive Risk Management
- Quality Assurance Audits
- Pharmacovigilance
- Drug Safety Compliance
- Validation Protocols
- Risk Assessments
- Lifecycle Management
- Implementing Corrective Actions
- Leading Validation Projects
- IQ/OQ/PQ
- Facility Mappin Studies
- Lane Studies
- Cross-functional Team Collaboration
- Quality System Documents Management
- 21 CFR Part 11
Certification
- CITI- Good Clinical Practice Certification (US FDA focused)
- CITI- Human Subjects Protection (Biomedical) Certification
- Certified Diabetes Educator (CDE) - Certification Board for Diabetes Care and Education.
- CPR/AED Certification
License
Licensed Pharmacist, Ontario, Canada
Timeline
Hospital Pharmacist/Clinical Research Associate
Mount Sinai Hospital
09.2022 - 12.2024
Clinical Pharmacist
Shoppers Drug Mart Pharmacy
08.2020 - 08.2022
Quality Assurance and Compliance Specialist
BioScript Solutions- A&D Wholesale
06.2019 - 07.2020
QA Compliance Seasonal Associate
Innomar Strategies
01.2017 - 10.2019
Regulatory Affairs Associate – Compliance
Amneal Pharmaceuticals
07.2015 - 09.2017
Master of Science - Translational Pharmacology and Clinical Research
Ohio State University
Non-Degree Seeking Classes - Pharmaceutical Sciences
University of Toronto
Bachelor of Pharmacy -
L.J. Institute of Pharmacy (GTU)
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