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Nirali Patel

@niralipatel4

Clinical Research Coordinator at Hartford Hospital supporting compliant trial operations, participant visits, and accurate EDC/OnCore data.

United States

Message

At Hartford Hospital, I support clinical trial operations from start-up through participant visits and follow-up. I use EPIC chart review and protocol eligibility criteria to support participant pre-screening and recruitment.

I prepare IRB submissions and regulatory documentation, including essential documents, regulatory binders, participant binders, and training records. I also coordinate study visits and follow-up activities.

At IQVIA, I supported CRAs and start-up teams by maintaining TMF/eTMF completeness and filing accuracy across clinical trial programs. I performed recurring QC reviews and reconciled documentation to support inspection readiness.

At PPD, I oversaw regulatory documentation for 70+ sites across 9 studies in the US and Canada. Earlier, at Zydus Pharmaceuticals, I supported monitoring across 10+ trials and contributed to 95% query resolution within 48 hours.

Experience

Work history, roles, and key accomplishments

Current

Clinical Research Coordinator

Current

Hartford Hospital

Oct 2025 - Present (1 year)

Support clinical trial operations across start-up, recruitment, participant visits, documentation, and sponsor/study-team communication. Conduct participant pre-screening and recruitment using EPIC chart review and protocol eligibility criteria.

Epic OnCore EDC IRB Submission Regulatory Documentation HIPAA PHI Privacy AE SAE Documentation Participant Recruitment Visitor Coordination

Clinical Trials Assistant II

IQVIA

May 2024 - Sep 2025 (1 year 4 months)

Supported CRAs and start-up teams by maintaining TMF/eTMF completeness, quality control, and filing accuracy across multiple clinical trial programs. Coordinated monitoring follow-up support and essential document review.

TMF ETMF Quality Control Essential Document Collection Regulatory Compliance SOPs Document Management Site Communications

Clinical Trial Coordinator II

PPD

Jan 2021 - Apr 2023 (2 years 3 months)

Oversaw documentation and regulatory file management for 70+ sites across 9 clinical studies, supporting inspection readiness and compliance standards. Trained newly hired Clinical Trial Coordinators on systems and documentation procedures.

ETMF Regulatory Documentation Inspection Readiness Training Document Review Clinical Studies Compliance

Clinical Research Associate

Zydus Pharmaceuticals

May 2018 - Oct 2020 (2 years 5 months)

Supported site monitoring activities across 10+ clinical trials, reinforcing source documentation accuracy, protocol adherence, and GCP compliance. Trained 15+ site personnel on protocol requirements and eTMF processes.