Clinical Research, Clinical Quality Assurance, Drug Safety

PROFESSIONAL SUMMARY

Accomplished Clinical Research Professional with over 7 years of experience in Clinical Quality Assurance (CQA) within CRO and pharmaceutical sectors. Proficient in conducting risk-based audits (Investigator Site, Vendor, and Process), meticulously reviewing clinical trial documentation and managing Quality Management Systems (QMS) to ensure compliance with ICH-GCP E6(R2) and regulatory standards (USFDA). Adaptable and committed to continuous learning with additional experience as a Pharmacy Technician, which enhancing healthcare knowledge and ensuring career continuity. Dedicated to upholding work ethics, research integrity, fostering collaboration and prioritizing patient safety. KEY SKILLS

Technical Skills: ICH-GCP E6(R2), Regulatory Compliance (USFDA 21 CFR Part 11, 50, 54, 56, 312), Risk-Based Audit, QMS Soft Skills: Attention to Detail, Analytical Thinking, Process Improvement, Cross-Functional Collaboration, Mentoring, Project Managment, Time Management

Tools & Software: Veeva Vault (e-QMS, e-TMF), Medidata RAVE, Advarra (e-Regulatory), Oracle Argus Safety, MedDRA, Microsoft Office Suite (PowerPoint, Excel, Word)

Sr. Quality Assurance Specialist (GCP-CQA) -

Shionogi Inc. (Contract)

Sr. Quality Assurance Specialist (GCP-QA) -

Cliantha Research

Quality Assurance Associate (GCP-QA) -

Sun Pharmaceutical Industries Limited

Phase-I (BA/BE, FIH): Oncology, Cardiology, Gastroenterology, Dermatology Phase-II : Oncology, Infectious Disease

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Association of Clinical Research Professionals (ACRP) -

Juhi Shah

Clinical Quality Assurance, GCP-QA

************@*****.*** Madison, New Jersey - 07940 linkedin.com/in/juhishah-crp 732-***-**** No Visa Sponsorship Required Fully Authorized to Work PROFESSIONAL EXPERIENCE

03/2024 07/2024

Madison, New Jersey - U.S.A.

Conducted risk-based audits, such as investigator site, vendor, process audit and ensuring ICH-GCP E6(R2), USFDA and HIPAA compliance, improving adherence analytically by 10%

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Collaborated on the review of clinical trial documents, including Protocols, Case Report Forms (CRFs), Informed Consent Forms

(ICFs), Clinical Study Reports (CSRs), Trial Master File (e-TMF) using Veeva Vault and Medidata RAVE to boost data reliability by 15%

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Enhanced scientific quality audit report efficiency by 10% through cross-functional collaboration and effective use of collaboration platforms to improve accuracy and clarity

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Managed the Quality Management System (QMS) tracker by reviewing SOPs, Deviations, CAPA, Change Control and Calibration Records, reducing errors by 10%

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08/2019 03/2023

Vadodara, Gujarat - India

Led risk-based clinical study audits (investigator site, vendor, process) resulting in a 25% enhancement in regulatory compliance adherence

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Reviewed and analyze critical clinical trial documents (Protocols, CRFs, ICFs, CSRs, e-TMF), ensuring data accuracy and integrity, leading to a 20% increase in reliability

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Streamlined the QMS tracker by reviewing and approving SOPs, Deviations, CAPA, Change Control, driving a 15% reduction in errors

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Utilized Excel, PowerPoint, Word to craft detailed QA audit reports, offer tailored guidance and coach junior auditors and clinical staff, leading to a 15% increase in compliance and elevating quality, efficiency and customer satisfaction

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Aligned project timelines with regulatory deadlines and meticulously evaluated risk factors to ensure data integrity and compliance across diverse initiatives

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03/2017 08/2019

Vadodara, Gujarat - India

THERAPEUTIC AREAS

03/2017 07/2024

Professional Association / Member

11/2024 Present

EDUCATION

M.Sc. Clinical Research -

ICRI - Cranfield University

B.Pharmacy -

Sardar Patel University

REFERENCES

Available upon request

07/2010 10/2012

India - U.K.

07/2006 04/2010

India

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