Nidhi Kadakia

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Regulatory Coordinator

Clinical Research Regulatory Coordinator at Salyx who improved document accessibility by 20% and supported faster site activation.

United StatesRegulatory Coordinator at Clinical Research

Experience

Regulatory Coordinator - Clinical Research
Supported clinical trial documentation and compliance with FDA, Health Canada, and GCP guidelines. Managed lead tracking metrics in CTMS, improving document accessibility by 20% and reducing site activation timelines by 15%.
Clinical Trial DocumentationFDA RegulationsGCPCTMSDocument ManagementSite Activation
Investigations Intern
Assessed compliance with FDA regulations for drugs, medical devices, biologics, and controlled substances. Prepared regulatory reports and supported adverse event reporting, resolving 15+ compliance cases and reducing investigation timelines by 30%.
FDA RegulationsRegulatory ComplianceAdverse Event ReportingCase ManagementCross Functional Collaboration
Clinical Coordinator
Coordinated clinical research activities in compliance with HIPAA, GDPR, GCP, and CFR. Led IRB submissions, CTAs, and CAPA processes, reducing approval timelines by 30% and overseeing participant recruitment and informed consent.
Clinical ResearchIRB SubmissionCTACAPAGCPHIPAAGDPRParticipant RecruitmentInformed Consent Forms
Clinical Research Assistant
Collected and maintained clinical trial data in REDCap, contributing to a 40% reduction in data queries. Ensured proper completion of informed consent forms, CRFs, and essential regulatory documents, and participated in SOP development and quality reviews.
Clinical Data ManagementREDCapInformed Consent FormsCRFSOP DevelopmentQuality Assurance

Education

Northeastern University
Master of Science in Regulatory Affairs from Northeastern University, completed in March 2025.
Master of Science in Regulatory Affairs from Northeastern University, completed in March 2025.
Harvard University
Completed a certificate in Prescription Drug Regulation, Cost, and Access: Current Controversies in Context from Harvard University in September 2023.
Completed a certificate in Prescription Drug Regulation, Cost, and Access: Current Controversies in Context from Harvard University in September 2023.
NIDA Clinical Trials Network
Completed a certificate in Good Clinical Practice from NIDA Clinical Trials Network in May 2023.
Completed a certificate in Good Clinical Practice from NIDA Clinical Trials Network in May 2023.
Sumandeep Vidyapeeth
Doctor of Pharmacy from Sumandeep Vidyapeeth, completed in August 2022.
Doctor of Pharmacy from Sumandeep Vidyapeeth, completed in August 2022.

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Experience

Regulatory Coordinator - Clinical Research

Supported clinical trial documentation and compliance with FDA, Health Canada, and GCP guidelines. Managed lead tracking metrics in CTMS, improving document accessibility by 20% and reducing site activation timelines by 15%.

Clinical Trial DocumentationFDA RegulationsGCPCTMSDocument ManagementSite Activation

Investigations Intern

Assessed compliance with FDA regulations for drugs, medical devices, biologics, and controlled substances. Prepared regulatory reports and supported adverse event reporting, resolving 15+ compliance cases and reducing investigation timelines by 30%.

FDA RegulationsRegulatory ComplianceAdverse Event ReportingCase ManagementCross Functional Collaboration

Clinical Coordinator

Coordinated clinical research activities in compliance with HIPAA, GDPR, GCP, and CFR. Led IRB submissions, CTAs, and CAPA processes, reducing approval timelines by 30% and overseeing participant recruitment and informed consent.

Clinical ResearchIRB SubmissionCTACAPAGCPHIPAAGDPRParticipant RecruitmentInformed Consent Forms

Clinical Research Assistant

Collected and maintained clinical trial data in REDCap, contributing to a 40% reduction in data queries. Ensured proper completion of informed consent forms, CRFs, and essential regulatory documents, and participated in SOP development and quality reviews.

Clinical Data ManagementREDCapInformed Consent FormsCRFSOP DevelopmentQuality Assurance

Education

Northeastern University

Master of Science in Regulatory Affairs from Northeastern University, completed in March 2025.

Harvard University

Completed a certificate in Prescription Drug Regulation, Cost, and Access: Current Controversies in Context from Harvard University in September 2023.

NIDA Clinical Trials Network

Completed a certificate in Good Clinical Practice from NIDA Clinical Trials Network in May 2023.

Sumandeep Vidyapeeth

Doctor of Pharmacy from Sumandeep Vidyapeeth, completed in August 2022.