Brian McCauley Jr

Clinical research professional with 4 years of experience supporting interventional and prospective clinical trials within a high-volume academic medical center. Extensive experience in regulatory documentation management, IRB tracking, monitoring visit preparation, EDC data oversight, and cross-functional coordination. Demonstrated ability to support study startup, maintain audit-ready files, and collaborate with investigators, research nurses, and external monitors to ensure compliance with ICH-GCP and FDA regulations.

Seeking to transition into sponsor-side clinical operations to support trial execution and operational excellence.

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

Bachelor of Science in Biological Sciences – Clemson University Honors College

Advanced Core in Medical Sciences (Post-Baccalaureate) – Lewis Katz School of Medicine at Temple University