Sri Ch
Clinical Research Specialist | Clinical Trials | EMR/EHR | Patient-Centered Innovation | Regulatory Compliance | STEM OPT | Actively Seeking Opportunities
- Role
- Clinical Research Coordinator at Center For Podiatry Care
- Location
- Augusta, GA, US
- LinkedIn followers
- 500 followers
About Sri Ch
Clinical Research Coordinator with 4+ years of experience supporting hospital-based and…
Experience
Clinical Research Coordinator
Aug 2024 — Present · Augusta, GA, US
Lead coordinator for three clinical trials:o Transform Study – AI-enabled coronary atherosclerosis imaging for cardiovascular outcome prediction.o Wound Graft Study – Efficacy of amniotic membrane grafts in diabetic foot ulcers.o BNZ (CAMPS Device Study) – Device-based therapy for non-healing wounds in high-risk patients.• Developed/submitted IRB applications; ensured FDA, HIPAA, and GCP compliance.• Managed AE/SAE documentation, FDA Form 3500A submissions, and maintained regulatory binders.• Conducted participant screening, eligibility assessments, and optimized recruitment timelines.• Executed CAPA processes, performed root cause analysis, and resolved audit findings.• Integrated Dexcom CGM data, HbA1c values, and adherence metrics for research analysis.• Collaborated with PIs, radiologists, and clinical staff to track enrollment and escalate safety events.• Managed AdvancedMD EHR data entry, imaging records, wound healing metrics, and risk profiles.
Education
Sacred Heart University
Master's degree
2022 — 2023
Vishnu Dental College, Bheemavaram
Bachelor's of dental surgery
2016 — 2021
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