• Executes, manages, and coordinates research protocols as directed by the Clinical Research Supervisor and/or Principal Investigator (PI) in the Department of Pediatrics.• Coordinates the data collection and operations of several concurrent clinical research studies under the guidelines of research protocols, UCSF and regulating agency policies.• Collect, manage, and analyze research data using electronic databases.• Collaborate with interdisciplinary teams including physicians, nurses, and statisticians to ensure study milestones are met.• Conducted study visits, informed consent procedures, administered questionnaires, collected medical history, and performed study procedures with a focus on patient safety and advocacy.

• Supported all aspects of study progress (from planning to close-out), assured adherence to intended timelines, and achieved study goals while ensuring quality in accordance with FDA, EMEA, GCP, and ICH guidelines.• Assisted with assigned aspects of clinical trials. This included various types of tracking and oversight of deliverables.• Assisted with the creation of study-level communication to internal and external parties as directed.• Assisted in monitoring the completeness and timeliness of trial-specific document submission to the Trial Master File and Investigator Site File.• Assisted with the review of case report forms, database setup (e.g., EDC, IRT, or other databases containing clinical data), and user testing.• Supported Investigator recruitment feasibility and collected essential documents.• Assisted the project team in the preparation and submission of documentation packages to Ethics and/or Biosafety Committees.• Collaborated with appropriate functional areas to forecast Investigational Medicinal Product and clinical trial supply needs, including tracking requests and resolving issues.• Assisted in the planning and execution of trial-level meetings, including meetings with vendors or consultants.• Provided administrative support and assisted the Clinical Operations team in the preparation of agendas, minutes, and tracking of action items, risks, and timeline maintenance for team meetings.• Provided support for inspection readiness.• Helped identify and resolve study-level administrative issues.

Base SAS programming