Hi, I'm
Harshani Jadav
Clinical Research Professional
4+
Years Of Experience
15+
Clinical Studies
6+
Professional Certifications
My Skill Set
Clinical Research Coordination, Regulatory Compliance & Data Integrity
Clinical Research Coordination
Coordinates participant recruitment, informed consent, and study workflows ensuring protocol adherence and efficient enrollment across clinical trials.
Regulatory & Audit Compliance
Ensures ICH-GCP, TCPS2, and REB compliance through structured documentation, audit readiness, and regulatory submission management.
Clinical Data & Quality Management
Maintains data accuracy using ALCOA+ principles, CTMS workflows, and deviation tracking to support audit-ready clinical datasets.
Why Choose Me
My Experience Area
Projects
My Amazing Works
Cyclosporine-Loaded Nano-Structured Lipid Carriers for Sustained Ophthalmic Delivery
Academic Research Project
Experience
Cliantha Research
Roles & Responsibilities
• Implemented ICH-GCP based pre-screening workflows, increasing participant eligibility rates by 27% across active clinical studies.
• Executed digital recruitment and CRM scheduling strategies, reducing call duration 15% while maintaining 98% CTMS data accuracy.
• Standardized ALCOA+ compliant data entry models, achieving 100% documentation compliance and minimizing audit deviations.
• Coordinated investigators and site teams, improving enrollment efficiency 35% through structured communication and real-time tracking.
• Optimized screening scripts through feedback cycles, increasing pre-screening conversion rates by 29% across study portfolios.
• Maintained TCPS2 and PHIPA confidentiality compliance, achieving zero deviations during sponsor audits through secure documentation handling.
JB Pharmaceuticals
Roles & Responsibilities
• Managed controlled document lifecycle processes, reducing retrieval time by 32% while maintaining full QMS compliance.
• Conducted internal audits using structured checklists, improving SOP adherence by 41% and reducing regulatory observations.
• Designed and monitored CAPA plans, reducing recurring deviations by 25% through root cause analysis documentation.
• Validated study records using ALCOA+ principles, improving audit readiness by 37% across verified quality systems.
• Supported CSV documentation and test protocol validation, improving process reproducibility by 33% across digital systems.
• Standardized QA templates and batch documentation, reducing update turnaround time by 28% through risk-based controls.
DEGREE
EDUCATION
PGD: Clinical Research, Pharmacovigilance & Regulatory Affairs
April 2024 – March 2025
Academy of Applied Pharmaceutical Sciences, North York, Canada
Master of Pharmacy
August 2019 – May 2021
Bachelor of Pharmacy
August 2015 – May 2019
Professional Recognition & Feedback
Highly Reliable Clinical Research Professional
Clinical Operations Manager
Cliantha Research
Strong Quality and Regulatory Focus
Quality Head
JB Pharmaceuticals