Clinical Researcher
Current• Experience in managing clinical trials, training physicians and staff on complex protocols, project administration, regulatory affairs, health education, event reporting, case report form development and community awareness in addition to office management and administration• Strong Strengths include: Interim Monitoring Visits, Site Initiation Visits, Source Data Verification, Source Data Review, Co-monitoring/In-house monitoring, Clinical Trial Management, Quality Assurance, Feasibility Studies, Audits and Inspections, Medical Chart Review and Data Abstraction. Delivery of Clinical Research and GCP trainings, Query resolution, Regulatory Compliance, Submissions to Ethic Committees, Management and Submission of SAEs, Site Selection visits, Drug accountability, Management of Central Clinical Files, Newsletter Production, CRF Review and Development, Enrollment Tracking, Management of IP/Study Supplies• Experience in site management, data review, regulatory, budget negotiation, data abstraction and query resolutions on site and virtual, researching medical malpractice and criminal law cases utilizing LexisNexis and related programs• Legal Areas: Medical Malpractice, Criminal, Entertainment, Tort• MS Office: Word, Excel, Access and PowerPoint; Google Cloud: Gmail, Drive, Docs, Vault; Knowledge of Statistical Packages: EpiInfo, SPSS and SAS; Remote Data Programs: Veeva, StudyHub, Medidata, InfoTrac, Rave, OnCore, Inform, Prism, Study Manager; Messaging Platforms: Microsoft Teams, Slack and CTMS• CITI, GCP and IATA Trained• General understanding of Medicare National Coverage Determinations and Standard of Care items to complete a Medicare Coverage Analysis • Growing knowledge of key research financial regulations regarding research (e.g., FDA / OHRP / ORI / DHHS / NIH)• Developed strategies to successfully drive site performance in meeting project objectives• Proven project management and research abilities with capacity to design, plan and implement ideas
