Clinical Research Coordinator at University of Pennsylvania (2022– Present)
Clinical Research Coordinator supporting interventional and prospective clinical trials
- Lead operational support for three concurrent clinical studies, ensuring regulatory documentation is complete, current, and audit-ready
- Manage IRB submissions, amendments, and continuing review renewals to maintain uninterrupted study compliance
- Maintain electronic regulatory binders and essential documents in accordance with ICH-GCP and institutional SOPs
- Track subject enrollment, CRF completion, and data query resolution within REDCap to support data integrity and milestone reporting
- Serve as primary liaison between investigators, research staff, and internal stakeholders regarding document status, regulatory timelines, and study progress
- Prepare documentation for sponsor monitoring visits and coordinate follow-up on monitoring observations and action items
- Coordinate study meetings and assist in preparation of study materials, regulatory correspondence, and operational trackers
- Support vendor communication and follow-up to ensure timely receipt of required study documentation
Clinical Research Coordinator at University of Pennsylvania - Gastroenterology Research Team (2025-11 – Present)
Lead operational support for three concurrent clinical studies in gastroenterology research
- Lead operational support for three concurrent clinical studies, ensuring regulatory documentation is complete, current, and audit-ready
- Manage IRB submissions, amendments, and continuing review renewals to maintain uninterrupted study compliance
- Maintain electronic regulatory binders and essential documents in accordance with ICH-GCP and institutional SOPs
- Track subject enrollment, CRF completion, and data query resolution within REDCap to support data integrity and milestone reporting
- Serve as primary liaison between investigators, research staff, and internal stakeholders regarding document status, regulatory timelines, and study progress
- Prepare documentation for sponsor monitoring visits and coordinate follow-up on monitoring observations and action items
- Coordinate study meetings and assist in preparation of study materials, regulatory correspondence, and operational trackers
Clinical Research Coordinator at University of Pennsylvania - Lung Transplant Outcomes Group (2024-08 – 2025-10)
Maintained audit-ready regulatory binders and coordinated participant scheduling for lung transplant outcomes studies
- Maintained audit-ready regulatory binders and ensured ongoing compliance with ICH-GCP standards
- Coordinated participant scheduling and ensured completion of required protocol procedures and documentation
- Prepared study documentation for monitoring review and addressed monitoring findings in collaboration with research staff
- Collaborated with clinical teams to ensure required testing and assessments were completed per protocol
Clinical Research Coordinator at University of Pennsylvania - Renal & Transplant Research (2022-01 – 2024-12)
Supported three investigator-initiated studies in renal and transplant research
- Supported three investigator-initiated studies, including a 2×2 factorial randomized interventional clinical trial
- Collected, reviewed, and reconciled essential regulatory documents to ensure accuracy and completeness
- Coordinated communication with physicians, research nurses, and administrative staff to facilitate protocol adherence
- Prepared study files for monitoring visits and supported timely resolution of monitoring observations and data queries
- Trained research coordinators on regulatory compliance, documentation standards, and protocol execution procedure
