Open to opportunities

Hardik Panchal

@hardikpanchal

I’m a Clinical Project Associate with 7+ years supporting Phase I–IV trials, ensuring data integrity, compliance, and audit readiness.

United States

Message

What I'm looking for

I’m looking for a clinical operations role where I can ensure Phase I–IV trial documentation quality, maintain data integrity in CTMS/eTMF/EDC systems, and support inspections through cross-functional collaboration and ICH-GCP compliance.

I support Phase I–IV clinical research studies as a Clinical Project Associate, focusing on regulatory compliance, clinical data management, and audit readiness. I review and verify patient source documents, laboratory reports, medical histories, and clinical data while maintaining confidentiality and HIPAA/GCP requirements.

Previously, as a Clinical Research Coordinator, I owned day-to-day site execution for interventional trials—covering study start-up, conduct, and close-out. I maintained audit-ready regulatory documentation, managed CTMS/EDC workflows for accurate data capture and query resolution, and supported monitoring visits, audits, and inspections, including documentation practices that improved site compliance and operational performance.

Earlier, as a Clinical Research Associate, I performed source data verification and source document review, tracked protocol deviations and adverse events (AEs/SAEs), and prepared monitoring visit reports under senior CRA guidance. Across roles, I’ve built strong quality and problem-solving habits using eTMF, CTMS, EDC systems, and tools including Medidata RAVE, REDCap, Epic, CRIO, and Veeva to keep data accurate, complete, and inspection-ready.

Experience

Work history, roles, and key accomplishments

Current

Clinical Project Associate

Current

Frenova Renal Research

Aug 2024 - Present (1 year 11 months)

Review and verify patient source documents, laboratory reports, and clinical data to ensure protocol compliance and data accuracy. Maintain trial documentation in eTMF/CTMS, perform quality control reviews, and coordinate discrepancy resolution to support audit readiness.

Clinical Data Management ETMF CTMS EHR EDC Systems REDCap Clinical Documentation Review Quality Control Data Reconciliation Regulatory Compliance ICH GCP HIPAA

Clinical Research Coordinator I

Frenova Renal Research

Oct 2022 - Aug 2024 (1 year 10 months)

Coordinate day-to-day execution of interventional clinical trials, supporting site start-up, conduct, and close-out activities. Manage regulatory documentation/TMF records, CTMS/EDC workflows, patient recruitment, and preparation for monitoring visits, audits, and inspections.

Clinical Operations Site Start Up TMF Regulatory Documentation CTMS EDC Query Resolution Patient Recruitment Monitoring Visits Inspections ICH GCP

Clinical Research Associate I

SUNY Upstate Medical University

Jan 2022 - Sep 2022 (8 months)

Support monitoring of Phase I–IV clinical trials across therapeutic areas under ICH-GCP, FDA regulations, and study protocols. Perform source data verification/review, track deviations/AEs/SAEs and queries, and maintain regulatory binders and eTMF for audit readiness.

Clinical Monitoring Phase IV Studies ICH GCP FDA Compliance ETMF Regulatory Binder

Clinical Research Assistant

Trinity Medical Cardiology Hospital

Aug 2020 - Nov 2020 (3 months)

Support cardiology clinical trials with patient enrollment, informed consent, data entry, and regulatory documentation. Assist with monitoring visits, audits, and investigational product accountability.

Clinical Research Support Clinical Trials Patient Enrollment Data Entry Regulatory Documentation Monitoring Visits Audit Investigational Product Accountability

Scientific Sales Executive

Sanofi India Ltd

Feb 2019 - Jan 2020 (11 months)

Promote cardiovascular and diabetes medicines to clinicians, including diabetologists and cardiologists, and support physician conversion to prescribing. Manage regional sales activities, educational programs/events, and sales operations to achieve sales targets.

Medical Sales Territory Management Sales Cycle Sales Targets

Business Executive

Biocon Limited

Oct 2017 - Feb 2019 (1 year 4 months)

Promote diabetes insulin therapies to diabetologists, nephrologists, and cardiologists. Conduct patient education and device demonstrations, support insulin supply to pharmacies/patients, and drive brand achievement and sales performance.

Pharmaceutical Sales Diabetes Focused Promotion Physician Engagement Patient Education Blood Sugar Camps Insulin Device Demonstrations Hospital And Clinic Coverage Territory Management