Lily C.

I am a clinical research professional with nearly a decade of experience spanning clinical operations, project management, quality assurance, regulatory affairs, clinical data management, and process improvement. My background includes Phase I–IV industry-sponsored, NIH-funded, and investigator-initiated research across CROs and academic medical centers. My expertise includes multi-site clinical trial management, study start-up, cross-functional leadership, vendor oversight, GCP compliance, audits, CAPA, risk-based quality management, and operational process improvement. Currently, I provide quality oversight across a 29-trial CRO portfolio, focusing on QMS remediation, inspection readiness, and strengthening operational efficiency. I bring a multidisciplinary foundation encompassing TMF/eTMF management, REDCap database development, CRF design, data cleaning, and query resolution, alongside hands-on clinical and laboratory research experience in phlebotomy, biospecimen management, participant assessments, and molecular biology techniques. This breadth allows me to approach research challenges from both operational and scientific perspectives. I hold an MS in Clinical Research and certifications in project management (PMP) and clinical research (ACRP-CP). I am available for remote contract and consulting opportunities across clinical operations, quality assurance, project management, regulatory operations, TMF/eTMF, and clinical data management.