Pankti Patel
ACRP-CP Certified | Clinical Research Associate (CRA) | Clinical Trial Associate (CTA)| Phase II–III Clinical Monitoring | Psychometric Assessments| Study Start-Up| Site Management •SDV•TMF • CTMS
- Role
- Cta and Clinical Research Associate at Cod Research
- Location
- Ontario, CA, US
- LinkedIn followers
- 500 followers
About Pankti Patel
ACRP-CP certified clinical research professional with experience executing Phase multi-site clinical trials across CRO and investigative site environments. Currently performing responsibilities in a dual Clinical Trial Associate (CTA) and Clinical Research Associate (CRA) capacity, managing site start-up, clinical monitoring activities, site coordination, TMF/CTMS oversight, regulatory documentation, and inspection readiness in compliance with ICH-GCP and global regulatory requirements. Conducts remote and on-site monitoring activities, protocol compliance oversight, and data quality review, ensuring accurate study conduct and regulatory adherence across participating sites. Experienced in cross-functional collaboration with clinical operations, data management, pharmacovigilance, and regulatory teams to ensure efficient trial execution and quality outcomes.Additional experience includes performing quality assurance activities in bioavailability/bioequivalence (BA/BE) studies involving healthy human subjects and serving as a psychometric rater in depression clinical trials, ensuring protocol adherence and reliability of clinical endpoint assessments. Holds a PhD in Pharmacology, bringing a strong scientific foundation and an operationally focused approach to clinical trial management and monitoring.
Experience
Cta and Clinical Research Associate
Nov 2023 — Present · Ontario, CA, US
Education
Rofel, Shri G.M.Bhilakhia College of Pharmacy
Bachelor of Pharmacy (B.Pharm.)
2008 — 2012
Shree Dhanvantary Pharmacy College - India
M.Pharm, Pharmacology
2012 — 2014
Institute of Pharmacy, Nirma University
Doctor of Philosophy - PhD, Pharmacology
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