▇ Managed multiple oncology clinical trials simultaneously including Investigator-Initiated Trials.▇ Managed all aspects of clinical data management including creation and collection of source documents, completion of case report forms, and tracking and reporting of serious adverse events. ▇ Analyzed information from medical records (clinic notes, pathology reports, radiology reports, patient questionnaires, etc.) to extract data for all assigned research protocols. ▇ Established and maintained procedures and systems for research coordination and data management. ▇ Assured ongoing compliance with all departmental, institutional, and federal requirements and regulations and department policies. ▇ Served as a resource to provide support and guidance to less experienced DCs and other study team members. ▇ Liaised with sponsors and the in-house monitoring team, scheduled monitoring visits, and addressed monitoring report findings. ▇ Lead preparation for quality control audits to verify the accuracy, completeness, and confidentiality of research data for internal and external audits addressing identified data deficiencies and developing corrective action plans post-audit

▇ Clinical Trials: Perform Study Coordinator responsibilities for pharmaceutical clinical trials that involve medications for adults with Hypertension, Covid, OCD, Depression and Women’s Health. Establish and retain functional relationships with sponsors to effectively communicate progress of clinical trials and patient/study related issues.▇ Data Management: Review data management queries for completeness and accuracy. Coordinate and oversee database management including subject tracking, medical records data entry and tracked critical study metrics into robust database. ▇ Research Projects: Manage clinical research projects from proposal through protocol development to completion. Coordinator all aspects of regulatory management for department’s research projects. ▇ GCP/IRB: Adhere to GCP, SOP standards. Serve as liaison to IRB and prepare applications, renewals, and other reports.▇ Coordinator: Initiate studies, screen patients for study eligibility to participate per protocol, inclusion/exclusion criteria and informed consent process. Perform clinical tasks including vital signs, height and weight, ECG, phlebotomy, specimen processing and packaging.